CARE-HK in HF: Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
Study Details
Study Description
Brief Summary
The CARE-HK in HF is a registry study based on the hypothesis that adherence to guidelines is associated with improved real-world outcomes for heart failure (HF) patients. For the purpose of this study, adherence to guidelines is defined as 1) adherence to potassium (sK+) monitoring recommendations, and 2) adherence to renin-angiotensin-aldosterone system inhibitor (RAASi) treatment recommendations, according to the most current local guidelines at the time of assessment.
The study aims to evaluate real-world RAASi treatment patterns in clinical practice compared with the guideline-directed medical therapy (GDMT) recommendations. Factors associated with patients achieving GDMT will be evaluated to identify potential barriers.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The study will have a 24-month enrolment period, followed by a 24-month follow-up period, resulting in a total study duration of 48 months.
At enrolment, relevant patient data will be retrospectively extracted from medical records for the 24 months prior to enrolment or since the time of HF diagnosis, as appropriate. After enrollment all patients will have between 24 months and 48 months of prospective follow-up.
There are no visits or procedures associated with the study, patients will follow routine clinical care, which may include in-person and/or virtual visits. The study protocol does not recommend the use of any specific treatments and no study medication is provided as part of participation. The nature and heterogeneity of HF means patients will be treated with different treatments over the course of the study, and at the discretion of their treating physician.
Patient data will be collected from patient records and/or during a routine clinical visit. This will include treatments prescribed, routine assessments and measurements collected at routine clinical visits, as well as hospitalisations and other relevant patient data.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Single Cohort Patient data will be collected from patient records and/or during a routine clinical visit. This will include treatments prescribed, routine assessments and measurements collected at routine clinical visits, as well as hospitalisations and other relevant patient data. |
Outcome Measures
Primary Outcome Measures
- Percentage of patients by RAASi optimisation overall [at 24-months following enrolment]
- Percentage of patients by RAASi optimisation following hyperkalaemic events [at 6-month intervals after a hyperkalaemic event]
- Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic events [at 24-months following enrolment]
Secondary Outcome Measures
- Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation [at 24-months following enrolment]
- Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment [up to 48 months following enrolment]
- Description and change of disease status measured by patient reported outcome (PRO) by RAASi treatment optimisation [at enrolment and at approximately 6-months intervals]
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.
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Patient has at least 1 record of left ventricular ejection fraction (LVEF) documented in patient medical record in the 24 months prior to signature of informed consent.
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Patient treated with angiotensin-converting enzyme inhibitors (ACEi) / angiotensin receptor blockers (ARB) / angiotensin receptor-neprilysin inhibitors (ARNi) at enrolment.
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Patient treated with or a candidate for treatment with mineralcorticoid receptor antagonist (MRA) per a relevant treatment guideline at enrolment.
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Patient at increased risk of hyperkalaemia due to one or more of the following:
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Current hyperkalaemia (sK+ >5.0 mEq/L) at enrolment
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Record of documented hyperkalaemia (sK+ >5.0 mEq/l) in the 24 months prior to signature of informed consent
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estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2, or Chronic Kidney Disease (CKD) stage ≥3b.
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Patient judged by the Investigator to have sufficient cognitive ability to participate
Exclusion Criteria:
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Patient on renal replacement therapy or mechanical circulatory support.
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Disease other than HF with expected survival <1 year.
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Patient is participating in, or being screened for, an interventional trial.
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Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
2 | UC San Diego Sulpizio Cardiovascular Center | La Jolla | California | United States | 92037 |
3 | Amicis Research Center | Northridge | California | United States | 91324 |
4 | Bridgeport Hospital | Bridgeport | Connecticut | United States | 06610 |
5 | Bethesda Hospital East | Boynton Beach | Florida | United States | 33425 |
6 | Clearwater Cardiovascular Consultants | Clearwater | Florida | United States | 33756 |
7 | Innovative Research of West Florida, Inc. | Clearwater | Florida | United States | 33756 |
8 | Inpatient Research Clinic, LLC | Hialeah | Florida | United States | 33013 |
9 | Clearwater Cardiovascular Consultants | Largo | Florida | United States | 33777 |
10 | D&H National Research Centers | Miami | Florida | United States | 33173 |
11 | Southwest Florida Research, LLC | Naples | Florida | United States | 34102-8143 |
12 | Peace River Cardiovascular Center | Port Charlotte | Florida | United States | 33952 |
13 | Clearwater Cardiovascular and Interventional Consultants | Safety Harbor | Florida | United States | 32695 |
14 | Florida Cardiology P.A | Winter Park | Florida | United States | 32792 |
15 | IACT Health | Columbus | Georgia | United States | 31904 |
16 | Cardiology Care Clinics | Eatonton | Georgia | United States | 31024 |
17 | NSC Research | Johns Creek | Georgia | United States | 30024 |
18 | Chicago Medical Research, LLC | Hazel Crest | Illinois | United States | 60429-2196 |
19 | Prairie Cardiovascular Consultants, Ltd. | Springfield | Illinois | United States | 62701 |
20 | Cardiovascular Medicine, P.C. | Davenport | Iowa | United States | 52803 |
21 | Central Cardiology Associates | Elizabethtown | Kentucky | United States | 42701 |
22 | Maine Health | Biddeford | Maine | United States | 04005 |
23 | Johns Hopkins University | Baltimore | Maryland | United States | 21218 |
24 | TidalHealth Peninsula Regional Inc. | Salisbury | Maryland | United States | 21801 |
25 | Ascension St. Mary's Hospital | Saginaw | Michigan | United States | 48601 |
26 | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | United States | 55407 |
27 | St. Louis Heart and Vascular | Bridgeton | Missouri | United States | 63044 |
28 | St. Louis University | Saint Louis | Missouri | United States | 63104 |
29 | Logan Health Research | Kalispell | Montana | United States | 59901 |
30 | Raritan Bay Primary and Cardiology Associates | Matawan | New Jersey | United States | 07747 |
31 | The Heart House | Sewell | New Jersey | United States | 08080 |
32 | Albany Stratton VA Medical Center | Albany | New York | United States | 12208 |
33 | Capital Cardiology Associates | Albany | New York | United States | 12211 |
34 | South Shore University Hospital | Bay Shore | New York | United States | 11706 |
35 | Focus Clinical Research Solutions | Charlotte | North Carolina | United States | 28204 |
36 | Nephrology Associates of Greater Cincinnati | Cincinnati | Ohio | United States | 45236 |
37 | Rama Research LLC | Marion | Ohio | United States | 43302 |
38 | The Heart and Medical Center | Durant | Oklahoma | United States | 74701 |
39 | Capital Area Research, LLC | Camp Hill | Pennsylvania | United States | 17011 |
40 | UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
41 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390-9047 |
42 | East Texas Cardiology PA | Houston | Texas | United States | 77002 |
43 | Biopharma Informatic, LLC | Houston | Texas | United States | 77084 |
44 | Texas Cardiology Associates of Houston | Kingwood | Texas | United States | 77339 |
45 | Complete Heart Care | McKinney | Texas | United States | 75071 |
46 | Baylor Scott & White Round Rock | Round Rock | Texas | United States | 78665 |
47 | Baylor Scott & White Health - Temple | Temple | Texas | United States | 76508 |
48 | Victoria Heart & Vascular Center | Victoria | Texas | United States | 77901 |
49 | Richmond Cardiology Associates | Mechanicsville | Virginia | United States | 23116 |
50 | William S. Middleton Memorial VA Hospital | Madison | Wisconsin | United States | 53705 |
51 | KH St. Josef Braunau | Braunau Am Inn | Austria | ||
52 | Allgemeines Krankenhaus der Stadt Wien | Wien | Austria | ||
53 | Imed-19 privat | Wien | Austria | ||
54 | Klinik Floridsdorf | Wien | Austria | ||
55 | Cliniques Universitaires de Bruxelles Hopital Erasme | Brussels | Belgium | ||
56 | Grand Hôpital de Charleroi | Charleroi | Belgium | ||
57 | AZ Sint-Blasius | Dendermonde | Belgium | ||
58 | CHU de Liège | Liège | Belgium | ||
59 | AZ Glorieux | Ronse | Belgium | ||
60 | Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS | Bologna | Italy | ||
61 | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Brescia | Italy | ||
62 | Azienda Ospedaliera Universitaria Arcispedale Sant'Anna | Ferrara | Italy | ||
63 | Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia | Foggia | Italy | ||
64 | Azienda Ospedaliera Universitaria "Federico II" | Napoli | Italy | ||
65 | IRCCS San Raffaele Pisana | Roma | Italy | ||
66 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | ||
67 | Hospital Universitario Virgen de las Nieves | Granada | Spain | ||
68 | Complejo Hospitalario de Jaen | Jaén | Spain | ||
69 | Complejo Hospitalario Universitario A Coruña | La Coruña | Spain | ||
70 | Hospital Universitario Ramon y Cajal | Madrid | Spain | ||
71 | Hospital Clinico Universitario Virgen de la Victoria | Málaga | Spain | ||
72 | Hospital Universitario Puerto Real | Puerto Real | Spain | ||
73 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | ||
74 | University Hospital Basel | Basel | Switzerland | ||
75 | Hôpitaux Universitaires de Genève - HUG | Geneva | Switzerland | ||
76 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | ||
77 | Kantonsspital St. Gallen | Saint Gallen | Switzerland | ||
78 | Buckinghamshire Healthcare NHS Trust | Amersham | United Kingdom | ||
79 | Bradford Royal Infirmary | Bradford | United Kingdom | ||
80 | Royal Devon and Exeter Hospital (Wonford) | Exeter | United Kingdom | ||
81 | Northwick Park Hospital | Harrow | United Kingdom | ||
82 | Barts Health NHS Trust | London | United Kingdom | ||
83 | King's College Hospital | London | United Kingdom | ||
84 | Derriford Hospital | Plymouth | United Kingdom | ||
85 | Whiston Hospital | Rainhill | United Kingdom |
Sponsors and Collaborators
- Vifor (International) Inc.
Investigators
- Study Director: Udo-Michael Goehring, MD, Vifor (International) Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HQ-NIS-CHF-07.2020