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GUIDE-HF: Hemodynamic-GUIDEd Management of Heart Failure

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03387813
Collaborator
(none)
2,358
Enrollment
134
Locations
3
Arms
64.6
Anticipated Duration (Months)
17.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

Condition or Disease Intervention/Treatment Phase
  • Device: CardioMEMS™ HF System
 N/A

Detailed Description

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.

The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).

The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.

Study Design

Study Type:
Interventional
Actual Enrollment :
2358 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Hemodynamic-GUIDEd Management of Heart Failure
Actual Study Start Date :
Mar 15, 2018
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Randomized Arm - Treatment Group

Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Device: CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
  • CardioMEMS HF System

    		•
    Experimental: Randomized Arm - Control Group

    Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

    Device: CardioMEMS™ HF System
    The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
    Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
  • CardioMEMS HF System

    		•
    Experimental: Single Arm

    Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

    Device: CardioMEMS™ HF System
    The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
    Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
  • CardioMEMS HF System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. (Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality [12 months post-implantation]

      The composite of: The number of recurrent HFHs The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy The number of deaths of any cause added together with equal weighting into a total number of events

    2. (Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality [12 months post-implantation]

      The composite outcome of: The number of recurrent HFHs The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy The number of deaths of any cause added together with equal weighting into a total number of events

    Secondary Outcome Measures

    1. (Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits [12 months post-implantation]

      The composite outcome of: The number of recurrent HFHs The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events

    2. (Randomized Arm) EQ-5D-5L [Baseline, 6, and 12 months post-implantation]

      Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire

    3. (Randomized Arm) KCCQ-12 [Baseline, 6, and 12 months post-implantation]

      Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    4. (Randomized Arm) 6MHW Test [Baseline, 6, and 12 months post-implantation]

      Six Minute Hall Walk (6MHW) Test Distance

    5. (Randomized Arm) HFHs [12 months post-implantation]

      The number of recurrent HFHs

    6. (Randomized Arm) Intravenous diuretic visits [12 months post-implantation]

      The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    7. (Randomized Arm) All-cause mortality [12 months post-implantation]

      The number of deaths of any cause

    8. (Randomized Arm) Safety: Freedom from DSRCs [12 months post-implantation]

      Freedom from device/system related complications (DSRCs)

    9. (Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits [12 months post-implantation]

      The composite outcome of: The number of recurrent HFHs The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events

    10. (Single Arm) HFHs post- vs. pre-implantation [12 months post-implantation]

      The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

    11. (Single Arm) HFHs [12 months post-implantation]

      The number of HFHs

    12. (Single Arm) Intravenous diuretic visits [12 months post-implantation]

      The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    13. (Single Arm) All-cause mortality [12 months post-implantation]

      The number of deaths of any cause

    14. (Single Arm) Safety: Freedom from DSRCs [12 months post-implantation]

      Freedom from DSRCs

    Other Outcome Measures

    1. (Randomized Arm) Cardiovascular mortality [12 months post-implantation]

      The number of deaths with cardiovascular cause

    2. (Randomized Arm) All-cause hospitalizations [12 months post-implantation]

      The number of hospitalizations of any cause

    3. (Randomized Arm) Frequency of subject PA pressure uploads [12 months post-implantation]

      The frequency of subject uploads of PA pressure

    4. (Randomized Arm) Frequency of clinician review of subject PA pressure uploads [12 months post-implantation]

      The frequency of clinician review of subject uploads of PA pressure

    5. (Randomized Arm) HF medication changes [12 months post-implantation]

      The number of changes in HF medications

    6. (Randomized Arm) PA pressure measurements [Baseline through 12 months post-implantation]

      PA pressure measurements

    7. (Randomized Arm) NT-proBNP (or BNP) [Baseline, 6, and 12 months post-implantation]

      NT-proBNP (or BNP) measurements

    8. (Randomized Arm) HFHs post- vs. pre-implantation [12 months post-implantation]

      The number of HFHs at 12 months post-implantation compared to the num ber of HFHs in the 12 months prior to implantation

    9. (Single Arm) EQ-5D-5L [Baseline, 6, and 12 months post-implantation]

      Health status as assessed by the EQ-5D-5L Questionnaire

    10. (Single Arm) KCCQ-12 [Baseline, 6, and 12 months post-implantation]

      Health status as assessed by the KCCQ-12

    11. (Single Arm) 6MHW Test [Baseline, 6, and 12 months post-implantation]

      6MHW Test Distance

    12. (Single Arm) Cardiovascular mortality [12 months post-implantation]

      The number of deaths of cardiovascular cause

    13. (Single Arm) All-cause hospitalizations [12 months post-implantation]

      The number of hospitalizations of any cause

    14. (Single Arm) Frequency of subject PA pressure uploads [12 months post-implantation]

      The frequency of subject uploads of PA pressure

    15. (Single Arm) Frequency of clinician review of subject PA pressure uploads [12 months post-implantation]

      The frequency of clinician review of subject uploads of PA pressure

    16. (Single Arm) HF medication changes [12 months post-implantation]

      The number of changes in HF medications

    17. (Single Arm) PA pressure measurements [Baseline through 12 months post-implantation]

      PA pressure measurements

    18. (Single Arm) NT-proBNP (or BNP) [Baseline, 6, and 12 months post-implantation]

      NT-proBNP (or BNP) measurements

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:
    1. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.

    1. GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.

    2. GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.

    3. HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:

    4. Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).

    5. Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).

    6. Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2

    7. ≥ 18 years of age

    8. Chest circumference of < 65 inches, if BMI is > 35 kg/m2

    9. Written informed consent obtained from subject

    10. Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements

    Exclusion Criteria:

    1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers)

    2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)

    3. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months

    4. NYHA Class IV HF patients with:

    5. Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤ 4, OR

    6. Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention

    7. Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis

    8. Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation

    9. Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor

    10. Implanted with mechanical right heart valve(s)

    11. Unrepaired severe valvular disease

    12. Pregnant or planning to become pregnant in the next 12 months

    13. An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine).

    14. History of current or recurrent (≥ 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis

    15. Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent

    16. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent

    17. Enrollment into another trial with an active treatment arm

    18. Anticipated life expectancy of < 12 months

    19. Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner-University Medical Center Phoenix Phoenix Arizona United States 85006
    2 Arizona Cardiovascular Research Center Phoenix Arizona United States 85016
    3 Phoenix Cardiovascular Research Group Phoenix Arizona United States 85018
    4 University of Arizona Tucson Arizona United States 85719
    5 Washington Regional Medical Center Fayetteville Arkansas United States 72703
    6 Baptist Health Medical Center Little Rock Arkansas United States 72205
    7 Arkansas Heart Hospital Little Rock Arkansas United States 72211
    8 John Muir Medical Center Concord California United States 94520
    9 Adventist Health St. Helena Deer Park California United States 94574
    10 Scripps Health La Jolla California United States 92037
    11 University of California at San Diego (UCSD) Medical Center La Jolla California United States 92037
    12 USC University Hospital Los Angeles California United States 90033
    13 Ronald Reagan UCLA Medical Center Los Angeles California United States 90095
    14 Eisenhower Medical Center Rancho Mirage California United States 92270
    15 Sutter Medical Center, Sacramento Sacramento California United States 95816
    16 Mercy Medical Group - Cardiology Sacramento California United States 95819
    17 San Diego Cardiac Center San Diego California United States 92123
    18 California Pacific Medical Center - Van Ness Campus San Francisco California United States 94109
    19 Ventura Cardiology Consultants Ventura California United States 93003
    20 University of Colorado Hospital Aurora Colorado United States 80045
    21 North Colorado Medical Center Greeley Colorado United States 80631
    22 South Denver Cardiology Associates PC Littleton Colorado United States 80120
    23 Hartford Hospital Hartford Connecticut United States 06106
    24 Yale New Haven Hospital New Haven Connecticut United States 06510
    25 George Washington University Hospital Washington District of Columbia United States 20037
    26 Bethesda Memorial Hospital Boynton Beach Florida United States 33466
    27 Morton Plant Hospital Clearwater Florida United States 33756
    28 Memorial Regional Hospital Hollywood Florida United States 33020
    29 First Coast Cardiovascular Institute Jacksonville Florida United States 32216
    30 Memorial Hospital Jacksonville Jacksonville Florida United States 32216
    31 Mercy Hospital Miami Florida United States 33133
    32 Advent Health Orlando Orlando Florida United States 32803
    33 Orlando Regional Medical Center Orlando Florida United States 32806
    34 Tampa General Hospital Tampa Florida United States 33606
    35 Piedmont Athens Regional Medical Center Athens Georgia United States 30606
    36 University Hospital Augusta Georgia United States 30901
    37 WellStar Kennestone Hospital Marietta Georgia United States 30060
    38 Northshore University HealthSystem Evanston Illinois United States 60201
    39 Midwest Cardiovascular Institute Naperville Illinois United States 60540
    40 Advocate Health and Hospitals Corporation Oakbrook Terrace Illinois United States 60181
    41 St. Vincent Hospital Indianapolis Indiana United States 46240
    42 Heart Center of Lake County Merrillville Indiana United States 46410
    43 Iowa Heart Center West Des Moines Iowa United States 50266
    44 Kansas University Medical Center Kansas City Kansas United States 66160
    45 Cardiovascular Research Institute of Kansas Wichita Kansas United States 67226
    46 Our Lady of the Lake Hospital Baton Rouge Louisiana United States 70808
    47 Cardiovascular Institute of the South Houma Louisiana United States 70361
    48 Louisiana State University Health Sciences Center New Orleans Louisiana United States 70112
    49 Ochsner Medical Center New Orleans Louisiana United States 70121
    50 Advanced Cardiovascular Specialists Shreveport Louisiana United States 71105
    51 Brigham and Women's Hospital Boston Massachusetts United States 02115
    52 University of Massachusetts Worcester Massachusetts United States 01655
    53 University of Michigan Ann Arbor Michigan United States 48104
    54 McLaren Health Care Corporation Auburn Hills Michigan United States 48326
    55 Henry Ford Hospital Detroit Michigan United States 48202
    56 Sparrow Clinical Research Institute Lansing Michigan United States 48912
    57 MidMichigan Medical Center-Midland Midland Michigan United States 48640
    58 Providence Hospital Southfield Michigan United States 48075
    59 Minneapolis Heart Institute Minneapolis Minnesota United States 55407
    60 University of Minnesota Medical Center Fairview Minneapolis Minnesota United States 55455
    61 Mayo Clinic Rochester Minnesota United States 55905
    62 St. Cloud Hospital Saint Cloud Minnesota United States 56303
    63 St. Luke's Hospital Kansas City Missouri United States 64111
    64 North Kansas City Hospital North Kansas City Missouri United States 64116
    65 Mercy Hospital St. Louis Saint Louis Missouri United States 63141
    66 BryanLGH Heart Institute Lincoln Nebraska United States 68506
    67 University of Nebraska Medical Center Omaha Nebraska United States 68198
    68 Renown Regional Medical Center Reno Nevada United States 89502
    69 Catholic Medical Center Manchester New Hampshire United States 03102
    70 Deborah Heart and Lung Center Browns Mills New Jersey United States 08015
    71 Hackensack University Medical Center Hackensack New Jersey United States 07601
    72 Saint Barnabas Medical Center Livingston New Jersey United States 07039
    73 Lourdes Cardiology Services Voorhees New Jersey United States 08043
    74 New Mexico Heart Institute Albuquerque New Mexico United States 87102
    75 New York University Hospital New York New York United States 10016
    76 Mount Sinai Hospital New York New York United States 10019
    77 New York-Presbyterian/Columbia University New York New York United States 10032
    78 Hudson Valley Cardiovascular Practice, P.C. Poughkeepsie New York United States 12601
    79 Rochester General Hospital Rochester New York United States 14621
    80 St. Francis Hospital Roslyn New York United States 11576
    81 Carolinas Medical Center Charlotte North Carolina United States 28203
    82 Vidant Medical Center Greenville North Carolina United States 27835
    83 NC Heart and Vascular Research Raleigh North Carolina United States 27607
    84 WakeMed Hospital Raleigh North Carolina United States 27610
    85 Akron City Hospital Akron Ohio United States 44309
    86 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    87 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    88 Ohio State University Columbus Ohio United States 43210
    89 Ohio Health Research Institute Columbus Ohio United States 43214
    90 St. Elizabeth Health Center Youngstown Ohio United States 44501
    91 Integris Baptist Medical Center Oklahoma City Oklahoma United States 73112
    92 Oklahoma Heart Hospital South Oklahoma City Oklahoma United States 73135
    93 Oklahoma Heart Institute at Utica Tulsa Oklahoma United States 74133
    94 Providence Heart and Vascular Portland Oregon United States 97225
    95 Abington Memorial Hospital Abington Pennsylvania United States 19001
    96 Pinnacle Health System Harrisburg Pennsylvania United States 17105
    97 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    98 Lancaster General Hospital Lancaster Pennsylvania United States 17603
    99 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    100 Albert Einstein Medical Center Philadelphia Pennsylvania United States 19141
    101 Allegheny General Hospital - ASRI Pittsburgh Pennsylvania United States 15212
    102 The Reading Hospital and Medical Center West Reading Pennsylvania United States 19611
    103 Main Line Health Center/Lankenau Hospital Wynnewood Pennsylvania United States 19096
    104 Rhode Island Hospital Providence Rhode Island United States 02903
    105 Prisma Health-Midlands Columbia South Carolina United States 29203
    106 Greenville Health System Greenville South Carolina United States 29605
    107 Sanford USD Medical Center Sioux Falls South Dakota United States 57117
    108 Tennova Healthcare - Turkey Creek Medical Center Knoxville Tennessee United States 37920
    109 Methodist University Hospital Memphis Tennessee United States 38104
    110 St Thomas Hospital Nashville Tennessee United States 37205
    111 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    112 Acension Texas Cardiovascular Austin Texas United States 78705
    113 Austin Heart Austin Texas United States 78756
    114 Baylor University Hospital Dallas Texas United States 75246
    115 John Peter Smith Hospital Fort Worth Texas United States 76104
    116 Park Plaza Hospital Houston Texas United States 77004
    117 CHI St. Luke's Health Baylor College of Medicine Med. Ctr. Houston Texas United States 77030
    118 Memorial Hermann Hospital Houston Texas United States 77030
    119 The Methodist Hospital Houston Texas United States 77030
    120 Methodist Healthcare System of San Antonio San Antonio Texas United States 78229
    121 Virginia Heart - The Cardiovascular Group, P.C. Falls Church Virginia United States 22042
    122 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
    123 Bon Secours Heart & Vascular Institute Richmond Virginia United States 23226
    124 Winchester Medical Center Winchester Virginia United States 22601
    125 Providence Everett Medical Center Everett Washington United States 98206
    126 Swedish Medical Center - Heart & Vascular Seattle Washington United States 98122
    127 University of Washington Medical Center Seattle Washington United States 98195
    128 Aurora Medical Group Milwaukee Wisconsin United States 53215
    129 Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    130 Aspirus Wausau Hospital Wausau Wisconsin United States 54401
    131 Foothills Medical Centre Calgary Alberta Canada T2N2T9
    132 Vancouver General Hospital (U of BC) Vancouver British Columbia Canada V5Z 1M9
    133 Southlake Regional Health Centre Newmarket Ontario Canada L3Y 2P9
    134 Toronto General Hospital Toronto Ontario Canada M5G 2C4

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Study Director: Nessa Johnson, PhD, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT03387813
    Other Study ID Numbers:
    • CIP-10170
    First Posted:
    Jan 2, 2018
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Abbott Medical Devices
    Heart Failure
    Hemodynamic Monitoring
    CardioMEMS
    Pulmonary Artery Pressure
    Additional relevant MeSH terms:
    Heart Failure
    Heart Failure, Systolic
    Heart Failure, Diastolic

    Study Results

    No Results Posted as of Jun 24, 2022