HEART-FID: Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency
Sponsor
American Regent, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03037931
Collaborator
Duke Clinical Research Institute (Other)
3,068
346
2
74.5
8.9
0.1
Study Details
Study Description
Brief Summary
The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) distance for patients in heart failure with iron deficiency.
After an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment.
Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. In a subset of sites, a sub-study will be conducted to characterize serum phosphate levels over time in participants with heart failure and iron deficiency after dosing with FCM. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.
Study Design
Study Type:
Interventional
Actual Enrollment
:
3068 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency
Actual Study Start Date
:
Mar 15, 2017
Anticipated Primary Completion Date
:
Dec 1, 2021
Anticipated Study Completion Date
:
Jun 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ferric Carboxymaltose Ferric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by the results of iron indices. |
Drug: Ferric Carboxymaltose
Intravenous Iron
Other Names:
|
| Placebo Comparator: Placebo Normal saline 15ml - 2 doses 7 days apart repeated every 6 months. |
Drug: Placebo
Normal Saline Solution
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of death [1 year]
- Incidence of hospitalization for heart failure [1 year]
- Change in 6MWT distance [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adult (≥18 years of age) able to provide signed, written informed consent.
-
Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 2 weeks prior to randomization.
-
Able and willing to perform a 6MWT at the time of randomization.
-
Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical intervention including coronary artery bypass graft (CABG), valvular repair/replacement, or cardiac resynchronization therapy (CRT) device implantation.
- Left ventricular ejection fraction ≤ 40% obtained during the screening visit OR either of the following i. Historical value of ejection fraction ≤ 40% within 24 months of screening visit ii. Historical value of ejection fraction ≤ 30% within 36 months of screening visit
-
Hemoglobin >9.0 g/dL and < 13.5 g/dL (females) or <15.0 g/dL (males) within 28 days of randomization.
-
Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.Patients with screening ferritin <15 ng/mL must have documentation of an appropriate evaluation, as determined by the Principle Investigator, within 3 months of screening and prior to randomization.
-
Either documented hospitalization for heart failure within 12 months of enrollment or elavated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization. a. For patients in normal sinus rhythm: N-terminal-pro-brain natriuretic peptide (NT- proBNP) > 600 pg/mL (or BNP >200 pg/mL) . b . For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL) .
Exclusion Criteria:
-
Known hypersensitivity reaction to any component of FCM.
-
History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.
-
Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment.
-
Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention.
-
Current atrial fibrillation or atrial flutter with a mean ventricular response rate
100 per minute (at rest).
-
Current or planned mechanical circulatory support or heart transplantation.
-
Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
-
Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).
-
Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
-
Active gastrointestinal bleeding.
-
Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
-
Inability to return for follow up visits within the necessary windows
-
Concurrently in a study with investigational product.
-
No participants with Current COVID-19 Infection into the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Advanced Cardiovascular LLC | Alexander City | Alabama | United States | 35010 |
| 2 | Advanced Cardiovascular, LLC | Auburn | Alabama | United States | 36830 |
| 3 | IMC/Diagnostic & Medical Clinic | Mobile | Alabama | United States | 36604 |
| 4 | University of South Alabama | Mobile | Alabama | United States | 36617 |
| 5 | Alaska Heart & Vascular Institute | Anchorage | Alaska | United States | 99508 |
| 6 | Verde Valley Medical Center | Cottonwood | Arizona | United States | 86326 |
| 7 | Clinical Research Institute of Arizona, LLC | Surprise | Arizona | United States | 85374 |
| 8 | Carondelet Heart and Vascular Institute - Cardiology East | Tucson | Arizona | United States | 85710 |
| 9 | Sparks Regional Medical Center | Fort Smith | Arkansas | United States | 72901 |
| 10 | NEA Baptist Clinic | Jonesboro | Arkansas | United States | 72401 |
| 11 | Arkansas Heart Hospital | Little Rock | Arkansas | United States | 72211 |
| 12 | Westside Medical Associates of Los Angeles | Beverly Hills | California | United States | 90211 |
| 13 | Harbor-UCLA Medical Center | Carson | California | United States | 90509 |
| 14 | Valley Clinical Trials, Inc. | Covina | California | United States | 91723 |
| 15 | TriWest Research Associates, LLC | El Cajon | California | United States | 92020 |
| 16 | California Heart Specialists | Huntington Beach | California | United States | 92648 |
| 17 | First Valley Medical Group | Lancaster | California | United States | 93534 |
| 18 | Healthcare Partners Affiliation Medical Group | Long Beach | California | United States | 90806 |
| 19 | Axis Clinical Trials | Los Angeles | California | United States | 90036 |
| 20 | St. Joseph Heritage-Healthcare | Mission Viejo | California | United States | 92691 |
| 21 | Radin Cardiovascular Medical Group, Inc. | Newport Beach | California | United States | 92663 |
| 22 | Valley Clinical Trials, Inc. | Northridge | California | United States | 91325 |
| 23 | Pasadena Clinical Research | Pasadena | California | United States | 91105 |
| 24 | Eugene Soroka, MD Inc. | Port Hueneme | California | United States | 93041 |
| 25 | VA San Diego Health Care System | San Diego | California | United States | 92161 |
| 26 | Interventional Cardiology Medical Group | West Hills | California | United States | 91307 |
| 27 | South Denver Cardiology Associates, PC | Littleton | Colorado | United States | 80120 |
| 28 | Danbury Hospital | Danbury | Connecticut | United States | 06810 |
| 29 | Stamford Hospital | Stamford | Connecticut | United States | 06904 |
| 30 | Christiana Care | Newark | Delaware | United States | 19718 |
| 31 | Alfieri Cardiology | Wilmington | Delaware | United States | 19803 |
| 32 | Cardiology Associates of South Florida | Boynton Beach | Florida | United States | 33472 |
| 33 | Cardiovascular & Vein Center of Florida | Bradenton | Florida | United States | 34209 |
| 34 | Innovative Research of West Florida, Inc. | Clearwater | Florida | United States | 33756 |
| 35 | Avail Clinical Research, LLC | DeLand | Florida | United States | 32720 |
| 36 | Riverside Clinical Research | Edgewater | Florida | United States | 32132 |
| 37 | Memorial Regional Hospital | Hollywood | Florida | United States | 33021 |
| 38 | St. Vincent's Healthcare - Riverside | Jacksonville | Florida | United States | 32204 |
| 39 | UF Health Jacksonville | Jacksonville | Florida | United States | 32209 |
| 40 | St. Vincent's Healthcare - Southside Recruiting | Jacksonville | Florida | United States | 32216 |
| 41 | Mayo Clinic Florida | Jacksonville | Florida | United States | 32224 |
| 42 | Empire Clinical Research, LLC | Miami Lakes | Florida | United States | 33016 |
| 43 | ProLive Medical Research | Miami | Florida | United States | 33130 |
| 44 | Cordova Research Institute, LLC | Miami | Florida | United States | 33155 |
| 45 | Med-Care Research | Miami | Florida | United States | 33165 |
| 46 | ITB Research | Miami | Florida | United States | 33173 |
| 47 | Vista Health Research | Miami | Florida | United States | 33176 |
| 48 | Florida Hospital Transplant Institute | Orlando | Florida | United States | 32804 |
| 49 | Cardiology Partners Clinical Research Institute | Palm Beach Gardens | Florida | United States | 33410 |
| 50 | Springfield Medical Center | Panama City | Florida | United States | 32401 |
| 51 | Broward Research Center | Pembroke Pines | Florida | United States | 33024 |
| 52 | South Florida Research Solutions, LLC | Pembroke Pines | Florida | United States | 33026 |
| 53 | Cardiology Consultants | Pensacola | Florida | United States | 32501 |
| 54 | Avanza Medical Research Center | Pensacola | Florida | United States | 32503 |
| 55 | Professional Health Care of Pinellas | Saint Petersburg | Florida | United States | 33713 |
| 56 | Indian River Medical Center | Vero Beach | Florida | United States | 32960 |
| 57 | Cardiology Partners Clinical Research Institute | Wellington | Florida | United States | 33449 |
| 58 | Piedmont Heart Institute - Athens | Athens | Georgia | United States | 30606 |
| 59 | Piedmont Heart Institute | Atlanta | Georgia | United States | 30309 |
| 60 | University Cardiology Associates, LLC | Augusta | Georgia | United States | 30901 |
| 61 | Augusta University | Augusta | Georgia | United States | 30912 |
| 62 | Piedmont Heart Institute Fayetteville | Fayetteville | Georgia | United States | 30214 |
| 63 | Georgia Arrhythmia Consultants and Research Institute | Macon | Georgia | United States | 31201 |
| 64 | Mercer University | Macon | Georgia | United States | 31201 |
| 65 | Atlanta Vanguard Research Institute | Smyrna | Georgia | United States | 30082 |
| 66 | Saint Luke's Boise Medical Center | Boise | Idaho | United States | 83712 |
| 67 | Mount Sinai Hospital Medical Center - Department of Cardiology | Chicago | Illinois | United States | 60608 |
| 68 | Medicoricium, LLC | Fairview Heights | Illinois | United States | 62208 |
| 69 | Parkview Research Center | Fort Wayne | Indiana | United States | 46845 |
| 70 | Franciscan Physician Network - Indiana Heart Physicians | Indianapolis | Indiana | United States | 46237 |
| 71 | St. Vincent Medical Group | Indianapolis | Indiana | United States | 46260 |
| 72 | Indiana University Health Ball Memorial Hospital, Inc. | Muncie | Indiana | United States | 47303 |
| 73 | Reid Physician Associates / Reid Health | Richmond | Indiana | United States | 47374 |
| 74 | Beacon Medical Group Advanced Cardiovascular Specialists | South Bend | Indiana | United States | 46601 |
| 75 | Alexandria Cardiology Clinic | Alexandria | Louisiana | United States | 71301 |
| 76 | Heart Clinic of Hammond | Hammond | Louisiana | United States | 70403 |
| 77 | Cardiovascular Institute of the South | Houma | Louisiana | United States | 70360 |
| 78 | Tulane Heart & Vascular Institute | New Orleans | Louisiana | United States | 70112 |
| 79 | Ochsner Health System | New Orleans | Louisiana | United States | 70121 |
| 80 | Louisiana Heart Center | Slidell | Louisiana | United States | 70458 |
| 81 | Maine Medical Partners Maine Health Cardiology | Scarborough | Maine | United States | 04074 |
| 82 | Anne Arundel Health System Research Institute | Annapolis | Maryland | United States | 21401 |
| 83 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 84 | Suburban Hospital | Bethesda | Maryland | United States | 20814 |
| 85 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 86 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 87 | NECCR Prima Care Research, LLC | Fall River | Massachusetts | United States | 02721 |
| 88 | Genesys Regional Medical Center | Grand Blanc | Michigan | United States | 48439 |
| 89 | Western Michigan University Homer Stryker M.D. School of Medicine | Kalamazoo | Michigan | United States | 49008 |
| 90 | Michigan CardioVascular Institute at Covenant Medical Center | Saginaw | Michigan | United States | 48602 |
| 91 | Allina Health System, dba Abbott Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 92 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 93 | Cardiology Associates Research, LLC | Tupelo | Mississippi | United States | 38801 |
| 94 | North Kansas City Hospital | North Kansas City | Missouri | United States | 64116 |
| 95 | St. Louis Heart & Vascular, PC | Saint Louis | Missouri | United States | 63136 |
| 96 | Nebraska Heart Institute | Lincoln | Nebraska | United States | 68526 |
| 97 | CHI Health Research Center | Omaha | Nebraska | United States | 68124 |
| 98 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
| 99 | Red Rock Clinical Research, LLC | Las Vegas | Nevada | United States | 89146 |
| 100 | Monmouth Cardiology Associates, LLC | Eatontown | New Jersey | United States | 07724 |
| 101 | Englewood Health | Englewood | New Jersey | United States | 07631 |
| 102 | Advanced Heart & Vascular Institute of Hunterdon | Flemington | New Jersey | United States | 08822 |
| 103 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 104 | Saint Peter's University Hospital | New Brunswick | New Jersey | United States | 08901 |
| 105 | Saint Michael's Medical Center | Newark | New Jersey | United States | 07102 |
| 106 | Rutgers New Jersey Medical School | Newark | New Jersey | United States | 07103 |
| 107 | AtlantiCare Regional Medical Center | Pomona | New Jersey | United States | 08240 |
| 108 | The Valley Hospital | Ridgewood | New Jersey | United States | 07450 |
| 109 | Cardio Metabolic Institute | Somerset | New Jersey | United States | 08873 |
| 110 | Holy Name Medical Center | Teaneck | New Jersey | United States | 07666 |
| 111 | New York Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | United States | 11215 |
| 112 | Trinity Medical WNY, PC | Cheektowaga | New York | United States | 14227 |
| 113 | Mount Sinai Hospital | New York | New York | United States | 10029 |
| 114 | Rochester General Hospital | Rochester | New York | United States | 14621 |
| 115 | Richmond University Medical Center | Staten Island | New York | United States | 10310 |
| 116 | Stony Brook University Hospital | Stony Brook | New York | United States | 11794-7007 |
| 117 | Circuit Clinical | West Seneca | New York | United States | 14224 |
| 118 | Northtowns Cardiology, PLLC | Williamsville | New York | United States | 14221 |
| 119 | Asheville Cardiology Associates | Asheville | North Carolina | United States | 28803 |
| 120 | Duke University Heart Failure Research | Durham | North Carolina | United States | 27710 |
| 121 | Medication Management, LLC | Greensboro | North Carolina | United States | 27401 |
| 122 | Wake Forest University Health Sciences | High Point | North Carolina | United States | 27262 |
| 123 | Duke Cardiology of Lumberton | Lumberton | North Carolina | United States | 28358 |
| 124 | Monroe Biomedical Research | Monroe | North Carolina | United States | 28112 |
| 125 | Crossroads Clinical Research, Inc. | Mooresville | North Carolina | United States | 28117 |
| 126 | Pinehurst Medical Clinic, Inc. | Pinehurst | North Carolina | United States | 28374 |
| 127 | NC Heart & Vascular Research | Raleigh | North Carolina | United States | 27607 |
| 128 | WakeMed Health and Hospitals | Raleigh | North Carolina | United States | 27610 |
| 129 | PMG Research of Wilmington | Wilmington | North Carolina | United States | 28401 |
| 130 | Trinity Health Center - Medical Arts | Minot | North Dakota | United States | 58701 |
| 131 | Aultman Cardiology Clinical Trials | Canton | Ohio | United States | 44710 |
| 132 | The MetroHealth System | Cleveland | Ohio | United States | 44109 |
| 133 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 134 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 135 | North Ohio Heart Center | Elyria | Ohio | United States | 44035 |
| 136 | North Ohio Heart Center | Sandusky | Ohio | United States | 44870 |
| 137 | Heart House Research Foundation | Springfield | Ohio | United States | 45505 |
| 138 | South Oklahoma Heart Research, LLC | Oklahoma City | Oklahoma | United States | 73135 |
| 139 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 140 | Penn State Health Holy Spirit Medical Center Geisinger - Cardiology | Camp Hill | Pennsylvania | United States | 17011 |
| 141 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17602 |
| 142 | Drexel University | Philadelphia | Pennsylvania | United States | 19102 |
| 143 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 144 | University of Pennsylvania - Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | United States | 19104 |
| 145 | V.A. Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | United States | 15240 |
| 146 | Prisma Health | Columbia | South Carolina | United States | 29203 |
| 147 | Self Regional Hospital Research Center | Greenwood | South Carolina | United States | 29646 |
| 148 | Carolina Heart Specialists | Lancaster | South Carolina | United States | 29720 |
| 149 | Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc. | Rapid City | South Dakota | United States | 57701 |
| 150 | Stern Cardiovascular Foundation | Germantown | Tennessee | United States | 38138 |
| 151 | Tennova Healthcare-Turkey Creek Medical Center | Knoxville | Tennessee | United States | 37934 |
| 152 | Parkway Cardiology Associates, PC | Oak Ridge | Tennessee | United States | 37830 |
| 153 | Amarillo Hearth Clinical Research Institute, Inc. | Amarillo | Texas | United States | 79106 |
| 154 | PharmaTex Research | Amarillo | Texas | United States | 79106 |
| 155 | Dallas VA Medical Center | Dallas | Texas | United States | 75216 |
| 156 | Cardiovascular Research Institute of Dallas | Dallas | Texas | United States | 75231 |
| 157 | Southwest Family Medicine Associates | Dallas | Texas | United States | 75235 |
| 158 | Baylor University Medical Center | Dallas | Texas | United States | 75246 |
| 159 | Texas Health Research & Education Institute | Fort Worth | Texas | United States | 76104 |
| 160 | Texas Heart Institute | Houston | Texas | United States | 77030 |
| 161 | Houston Heart & Vascular Associates | Kingwood | Texas | United States | 77339 |
| 162 | Caprock Cardiac Center Research Institute, Inc. | Lubbock | Texas | United States | 79410 |
| 163 | Angelina Medical Research, LLC | Lufkin | Texas | United States | 75904 |
| 164 | North Dallas Research Associates | McKinney | Texas | United States | 75069 |
| 165 | North Texas Research Associates | McKinney | Texas | United States | 75701 |
| 166 | South Texas Cardiovascular Consultants, PLLC | San Antonio | Texas | United States | 78201 |
| 167 | Baylor Scott & White Medical Center | Temple | Texas | United States | 76508 |
| 168 | PharmaTex Research | Tyler | Texas | United States | 75701 |
| 169 | The University of Texas Health Center at Tyler | Tyler | Texas | United States | 75708 |
| 170 | Wichita Falls Heart Clinic | Wichita Falls | Texas | United States | 76301 |
| 171 | Advanced Clinical Research/Intermountain Heart Center PC | West Jordan | Utah | United States | 84088 |
| 172 | The University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
| 173 | Stroobants Cardiovascular Center | Lynchburg | Virginia | United States | 24501 |
| 174 | Riverside Cardiology Specialists | Newport News | Virginia | United States | 23601 |
| 175 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
| 176 | Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J) | Richmond | Virginia | United States | 23249 |
| 177 | VCU Medical Center | Richmond | Virginia | United States | 23298 |
| 178 | Carilion Medical Center | Roanoke | Virginia | United States | 24014 |
| 179 | Selma Medical Associates | Winchester | Virginia | United States | 22601 |
| 180 | Providence Regional Medical Center Everett | Everett | Washington | United States | 98201 |
| 181 | Swedish Heart & Vascular-Advanced Cardiac Support Program | Seattle | Washington | United States | 98122 |
| 182 | Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington | United States | 99204 |
| 183 | CHI Franciscan Research Center | Tacoma | Washington | United States | 98405 |
| 184 | Walla Walla Clinic | Walla Walla | Washington | United States | 99362 |
| 185 | Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | United States | 98801 |
| 186 | Marshfield Clinic | Marshfield | Wisconsin | United States | 54449 |
| 187 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 188 | ProHealth Care Inc / Waukesha Memorial Hospital | Waukesha | Wisconsin | United States | 53188 |
| 189 | SWSLHD-Liverpool Hospital | Liverpool | New South Wales | Australia | 1871 |
| 190 | Sunshine Coast University Hospital | Birtinya | Queensland | Australia | 4575 |
| 191 | Cairns Hospital | Cairns | Queensland | Australia | 4870 |
| 192 | The Prince Charles Hospital | Chermside | Queensland | Australia | 4032 |
| 193 | Core Research Group | Milton | Queensland | Australia | 4064 |
| 194 | Gold Coast University Hospital | Southport | Queensland | Australia | 4215 |
| 195 | The Queen Elizabeth Hospital | Adelaide | South Australia | Australia | 5011 |
| 196 | SA Heart | Ashford | South Australia | Australia | 5035 |
| 197 | Flinders Medical Centre | Bedford Park | South Australia | Australia | 5042 |
| 198 | Lyell McEwin Hospital | Elizabeth Vale | South Australia | Australia | 5112 |
| 199 | Heart Lung Clinic | Darlinghurst | Sydney | Australia | |
| 200 | Royal Hobart Hospital | Hobart | Tasmania | Australia | 7000 |
| 201 | Royal Adelaide Hospital | Adelaide | Australia | 5000 | |
| 202 | Macquarie University - Clinical Trials Unit | Macquarie Park | Australia | 2109 | |
| 203 | John Hunter Hospital | New Lambton Heights | Australia | 2305 | |
| 204 | Epworth HealthCare Clinical Trials | Richmond | Australia | 3121 | |
| 205 | MHAT Puls | Blagoevgrad | Bulgaria | 2700 | |
| 206 | Multiprofile Hospital for Active Treatment: Department of cardiology | Gabrovo | Bulgaria | 5300 | |
| 207 | MHAT Haskovo AD | Haskovo | Bulgaria | 6304 | |
| 208 | Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology | Lom | Bulgaria | 3600 | |
| 209 | Medical Center Medconsult Pleven OOD | Pleven | Bulgaria | 5800 | |
| 210 | МC Hipokrena | Sevlievo | Bulgaria | 5400 | |
| 211 | Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology | Sofia | Bulgaria | 1113 | |
| 212 | Second Medical Center-Sofia, EEOD - Department of Cardiology | Sofia | Bulgaria | 1202 | |
| 213 | Second Multiprofile Hospital for Active Treatment | Sofia | Bulgaria | 1202 | |
| 214 | 5th City Hospital | Sofia | Bulgaria | 1233 | |
| 215 | National Multiprofile Transport Hospital Cardiology Clinic | Sofia | Bulgaria | 1233 | |
| 216 | Medical Center Hera EOOD - Office of Cardiology | Sofia | Bulgaria | 1510 | |
| 217 | Multiprofile Regional Hospital for Active Treatment | Veliko Tarnovo | Bulgaria | 5002 | |
| 218 | Medical Center Velingrad 2017" EOOD, Office of Cardiology | Velingrad | Bulgaria | 4600 | |
| 219 | University of Calbary | Calgary | Alberta | Canada | T2N 4Z6 |
| 220 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 221 | South Edmonton Cardiology Consultants | Edmonton | Alberta | Canada | T6L 6K3 |
| 222 | Royal Alexandria Hospital | Edmonton | Alberta | Canada | |
| 223 | Fraser Clinical Trials | New Westminster | British Columbia | Canada | V3L 3W4 |
| 224 | SMH Cardiology Clinical Trials | Surrey | British Columbia | Canada | V3V 0C6 |
| 225 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V6E 1M7 |
| 226 | Victoria Heart Institute Foundation | Victoria | British Columbia | Canada | V8R 4R2 |
| 227 | G.A. Research Associates, Ltd. | Moncton | New Brunswick | Canada | |
| 228 | Health Sciences Centre | Saint John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 229 | Nova Scotia Health Authority | Halifax | Nova Scotia | Canada | B3H 3A7 |
| 230 | Manna Research Inc., Burlington South | Burlington | Ontario | Canada | L7R 1A4 |
| 231 | Cambridge Cardiac Care Center | Cambridge | Ontario | Canada | N1R 6V6 |
| 232 | Vizel Cardiac Research | Cambridge | Ontario | Canada | N1R 7R1 |
| 233 | London Health Sciences Center (LHSC) | London | Ontario | Canada | N6A 5A5 |
| 234 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 235 | Sinai Health System - Mount Sinai Hospital | Toronto | Ontario | Canada | M5G 1X5 |
| 236 | Clinique de Cardiologie de Lévis | Lévis | Quebec | Canada | G6V 4Z5 |
| 237 | Montreal Heart Institute | Montréal | Quebec | Canada | H1T 1C8 |
| 238 | McGill University Health Centre (MUHC) | Montréal | Quebec | Canada | H4A 3J1 |
| 239 | Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval | Québec | Quebec | Canada | G1V 4G5 |
| 240 | CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges | Saint-Georges | Quebec | Canada | G5Y 4T8 |
| 241 | Recherche Medical St-Jerome Inc. | Saint-Jérôme | Quebec | Canada | J7Z 5T3 |
| 242 | Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec | Trois-Rivières | Quebec | Canada | G8Z 3R9 |
| 243 | Royal University Hospital | Saskatoon | Saskatchewan | Canada | S7N 0W8 |
| 244 | Interni kardiologicka klinika FN Brno | Brno | Czechia | 625 00 | |
| 245 | Kardiologicka ambulance | Chlumec Nad Cidlinou | Czechia | 50353 | |
| 246 | Centrum preventivní kardiologie, Karlovo nám. 32, | Prague | Czechia | 128 08 | |
| 247 | Centrum preventivní kardiologie | Prague | Czechia | 128 08 | |
| 248 | General University Hospital in Prague | Prague | Czechia | 128 08 | |
| 249 | General University Hospital | Prague | Czechia | 128 08 | |
| 250 | IKEM-Klinika kardiologie | Prague | Czechia | 140 21 | |
| 251 | JSC Evex Hospitals,Georgia | Batumi | Georgia | 6010 | |
| 252 | Clinic-LJ | Kutaisi | Georgia | 4600 | |
| 253 | Aleksandre Aladashvili Clinic LLC | Tbilisi | Georgia | 0102 | |
| 254 | Ltd Israel-Georgian Medical Research Clinic "Helsicore" | Tbilisi | Georgia | 0112 | |
| 255 | Ltd Pineo Medical Ecosistem | Tbilisi | Georgia | 0114 | |
| 256 | Acad. G. Chapidze Emergency Cardiology Center | Tbilisi | Georgia | 0159 | |
| 257 | Bokhua Memorial Cardiovascular Center | Tbilisi | Georgia | 0159 | |
| 258 | Tbilisi Heart and Vascular Clinic | Tbilisi | Georgia | 0159 | |
| 259 | Ltd TIM- Tbilisi Institute of Medicine | Tbilisi | Georgia | 0160 | |
| 260 | Georgian-Dutch Hospital | Tbilisi | Georgia | 0172 | |
| 261 | Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai | Budapest | Hungary | 1085 | |
| 262 | Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika | Budapest | Hungary | 1122 | |
| 263 | Debreceni Egyetem Klinikai Központ Kardiológiai Osztály | Debrecen | Hungary | 4032 | |
| 264 | Clinexpert Gyöngyös Kft | Gyöngyös | Hungary | 3200 | |
| 265 | Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház | Harkány | Hungary | 7815 | |
| 266 | Bács-Kiskun Megyei Kórház Kardiológiai Osztály | Kecskemet | Hungary | 6000 | |
| 267 | Andrea Hornyik, MD | Miskolc | Hungary | 3529 | |
| 268 | Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika, | Pecs | Hungary | 7624 | |
| 269 | Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály | Szolnok | Hungary | 5000 | |
| 270 | Belvárosi Egészségház Kft | Zalaegerszeg | Hungary | 8900 | |
| 271 | Daugavpils Regional Hospital | Daugavpils | Latvia | LV5417 | |
| 272 | Liepajas Regional Hospital | Liepaja | Latvia | LV3414 | |
| 273 | Pauls Stradins Clinical University Hospital | Riga | Latvia | LV1002 | |
| 274 | Riga East University hospital clinic Gailezers | Riga | Latvia | LV1038 | |
| 275 | The Hospital of Lithuanian | Kaunas | Lithuania | 50161 | |
| 276 | Klaipeda Seaman's Hospital | Klaipėda | Lithuania | 92288 | |
| 277 | Vilnius University Hospital Santaros Klinikos | Vilnius | Lithuania | 08661 | |
| 278 | Wellington Hospital | Newton | Wellington | New Zealand | 6021 |
| 279 | Totara Clinical Research, Health New Lynn | Auckland | New Zealand | 0600 | |
| 280 | North Shore Hospital | Auckland | New Zealand | 0622 | |
| 281 | Auckland City Hospital | Auckland | New Zealand | 1023 | |
| 282 | Middlemore Hospital | Auckland | New Zealand | 2025 | |
| 283 | Christchurch Heart Institute | Christchurch | New Zealand | 8140 | |
| 284 | Dunedin Hospital | Dunedin | New Zealand | 9016 | |
| 285 | Hauora Tairāwhiti Department of Cardiology | Gisborne | New Zealand | 4010 | |
| 286 | Hawke's Bay Hospital | Hastings | New Zealand | 4120 | |
| 287 | Hutt Hospital | Lower Hutt | New Zealand | 5010 | |
| 288 | Nelson Hospital | Nelson | New Zealand | 7010 | |
| 289 | Taranaki Base Hospital | New Plymouth | New Zealand | 4310 | |
| 290 | Rotorua Hospital | Rotorua | New Zealand | ||
| 291 | Clinical Horizons NEW ZEALAND LTD | Tauranga | New Zealand | 3112 | |
| 292 | Oddział Kardiologii WSzS nr 4 | Bytom | Poland | 41-902 | |
| 293 | Biokinetica S.A. Przychodnia Józefów | Józefów | Poland | 05-410 | |
| 294 | Centrum Medyczne Linden | Kraków | Poland | 30-394 | |
| 295 | 1 Wojskowy Szpital Klininiczny w Lublinie | Lublin | Poland | 20-049 | |
| 296 | Ko-Med Centra Kliniczne | Lublin | Poland | 20-362 | |
| 297 | Szpital Swietej Anny w Miechowie | Miechów | Poland | 32-200 | |
| 298 | Szpital Świętej Anny w Miechowie | Miechów | Poland | 32-200 | |
| 299 | Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna | Nowy Dwór Mazowiecki | Poland | 05-100 | |
| 300 | Zespol Opieki Zdrowotnej | Oława | Poland | 55-200 | |
| 301 | Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej | Toruń | Poland | 87-100 | |
| 302 | Uniwersyteckie Centrum Kliniczne | Warszawa | Poland | 02-097 | |
| 303 | Centrum Medyczne K2J2 | Wołomin | Poland | 05-200 | |
| 304 | Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego | Wrocław | Poland | 50-556 | |
| 305 | 4th Military Hospital | Wrocław | Poland | 50-981 | |
| 306 | Proximum Centrum Usług Medycznych NZOZ | Wrocław | Poland | 53-428 | |
| 307 | Marcin Ogórek, MD, PhD | Łódź | Poland | 94-048 | |
| 308 | Municipal Autonomous Healthcare Institution "City Clinical Hospital #6 | Chelyabinsk | Russian Federation | 454017 | |
| 309 | Municipal Autonomous Healthcare Institution | Chelyabinsk | Russian Federation | 454017 | |
| 310 | Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases | Kemerovo | Russian Federation | 650002 | |
| 311 | State Budgetary Healthcare Institution of Moscow city "Moscow | Moscow | Russian Federation | 117292 | |
| 312 | Private Medical Institution "Euromedservice | Pushkin | Russian Federation | 196603 | |
| 313 | State Budgetary Institution of Ryazan Region | Ryazan | Russian Federation | 390026 | |
| 314 | JSC Polyclinic Complex | Saint Petersburg | Russian Federation | 190013 | |
| 315 | Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital" | Saint Petersburg | Russian Federation | 195257 | |
| 316 | LLC "Scientific Research Center Eco-Safety" | Saint Petersburg | Russian Federation | 196143 | |
| 317 | JSC Polyclinic Complex | Saint-Petersburg | Russian Federation | 190013 | |
| 318 | State Healthcare Institution | Saratov | Russian Federation | 410002 | |
| 319 | Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia | Saratov | Russian Federation | 410054 | |
| 320 | Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze | St. Petersburg | Russian Federation | 192242 | |
| 321 | Saint Petersburg Research Institute of Emergency Medicine | St. Petersburg | Russian Federation | 192242 | |
| 322 | LLC X7 Clinical Research | St. Petersburg | Russian Federation | 194156 | |
| 323 | Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center" | Ivano-Frankivs'k | Ukraine | 76025 | |
| 324 | Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department | Kharkiv | Ukraine | 61058 | |
| 325 | Scientific Medical Complex "University Clinic" of Kharkiv | Kharkiv | Ukraine | 61157 | |
| 326 | MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2 | Kharkiv | Ukraine | 61176 | |
| 327 | Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council | Kryvyi Rih | Ukraine | 50031 | |
| 328 | "Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City | Kyiv, | Ukraine | 01601 | |
| 329 | Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv | Kyiv | Ukraine | 01103 | |
| 330 | Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv | Kyiv | Ukraine | 01601 | |
| 331 | Communal non-profit enterprise Kyiv City Clinical Hospital №1 | Kyiv | Ukraine | 02091 | |
| 332 | Kyiv City Clinical Hospital of Emergency Aid, | Kyiv | Ukraine | 02166 | |
| 333 | Kyiv City Clinical Hospital of Emergency Aid | Kyiv | Ukraine | 02166 | |
| 334 | Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway" | Kyiv | Ukraine | 03049 | |
| 335 | National Scientific Center Institute of Cardiology of M.D | Kyiv | Ukraine | 03680 | |
| 336 | State Institution "National Scientific Center "Institute of Cardiology | Kyiv | Ukraine | 03680 | |
| 337 | Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL" | Kyiv | Ukraine | 04050 | |
| 338 | Medical Centre of LLC | Kyiv | Ukraine | 04050 | |
| 339 | MNPE "Lviv City Clinical Hospital No.5" | Lviv | Ukraine | 79000 | |
| 340 | Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical | Lviv | Ukraine | 79041 | |
| 341 | Vinnytsia Regional Clinical Hospital of Veterans of War | Vinnytsia | Ukraine | 21005 | |
| 342 | "Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology" | Vinnytsia | Ukraine | 21029 | |
| 343 | Communal Non-Profit Enterprise "City | Zaporizhzhia | Ukraine | 69001 | |
| 344 | Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine, | Zaporizhzhia | Ukraine | 69063 | |
| 345 | Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council, | Zaporizhzhia | Ukraine | 69600 | |
| 346 | Communal Enterprise "Hospital №1" of Zhytomyr City Council | Zhytomyr | Ukraine | 10002 |
Sponsors and Collaborators
- American Regent, Inc.
- Duke Clinical Research Institute
Investigators
- Study Chair: Adrian F Hernandez, MD, Duke Clinical Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
American Regent, Inc.
ClinicalTrials.gov Identifier:
NCT03037931
Other Study ID Numbers:
- 1VIT15043
First Posted:
Jan 31, 2017
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: