Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
CARE-HK
1 other identifier
observational
2,636
7 countries
116
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 adherence to RAASi treatment recommendations, according to the AHA/ACC and ESC guidelines. Objectives relating to patiromer effectiveness will only be evaluated if a sufficient number of patients are available. The study aims to evaluate in patients at high risk of hyperkalaemia; patients treated with ACEi/ARB/ARNi, and either treated with or candidates for treatment with MRA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Typical duration for all trials
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2021
CompletedStudy Start
First participant enrolled
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedNovember 4, 2024
April 1, 2024
2.9 years
April 6, 2021
October 31, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of patients by RAASi optimisation
overall
at 6-months intervals
Percentage of patients by RAASi dose modification following hyperkalaemic episodes
RAASi
at 6-month intervals after a hyperkalaemic episode
Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic
episodes
at 6-months following enrolment
Secondary Outcomes (3)
Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation
at 6-months following enrolment
Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment
up to 6 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
Study Arms (1)
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.
Eligibility Criteria
To the extent possible, representative sites (e.g., cardiologists and nephrologists) reflective of the treatment patterns within each country will be recruited. All patients treated for chronic HF during the enrolment period will be assessed for eligibility, and all eligible patients will be consecutively proposed to enrol in the study as they present for a routine clinical visit (in-person or virtual visits) in order to avoid potential selection bias.
You may qualify if:
- Adult aged ≥18 years at enrolment.
- Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.
- Patient has at least 1 record of LVEF documented in patient medical record in the 24 months prior to signature of informed consent. NOTE: If the proportion of patients with HFpEF exceeds 20% of the target sample size, enrolment of patients with an LVEF ≥50% may be capped.
- Patient treated with ACEi/ARB/ARNi at enrolment.
- Patient treated with or a candidate for treatment with MRA per a relevant treatment guideline (e.g., HF, CKD, resistant hypertension) at enrolment.
- Patient at increased risk of hyperkalaemia due to one or more of the following:
- Current hyperkalaemia (sK+ \>5.0 mEq/l) at enrolment
- Record of documented hyperkalaemia (sK+ \>5.0 mEq/l) in the 24 months prior to signature of informed consent
- eGFR \<45 ml/min/1.73 m2, or CKD Stage ≥3b.
- Patient judged by the Investigator to have sufficient cognitive ability to participate.
- Signed informed consent provided
You may not qualify if:
- Patient on renal replacement therapy or mechanical circulatory support.
- Disease other than HF with expected survival \<1 year.
- Patient is participating in, or being screened for, an interventional trial, with the exception of interventional trials relating to SARS-CoV-2.
- Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (116)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, 92037, United States
Amicis Research Center
Northridge, California, 91324, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Bethesda Hospital East
Boynton Beach, Florida, 33425, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Inpatient Research Clinic, LLC
Hialeah, Florida, 33013, United States
Clearwater Cardiovascular Consultants
Largo, Florida, 33777, United States
D&H National Research Centers
Miami, Florida, 33173, United States
Southwest Florida Research, LLC
Naples, Florida, 34102-8143, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, 33952, United States
Clearwater Cardiovascular and Interventional Consultants
Safety Harbor, Florida, 32695, United States
Florida Cardiology P.A
Winter Park, Florida, 32792, United States
IACT Health
Columbus, Georgia, 31904, United States
Cardiology Care Clinics
Eatonton, Georgia, 31024, United States
NSC Research
Johns Creek, Georgia, 30024, United States
Chicago Medical Research, LLC
Hazel Crest, Illinois, 60429-2196, United States
Prairie Cardiovascular Consultants, Ltd.
Springfield, Illinois, 62701, United States
Cardiovascular Medicine, P.C.
Davenport, Iowa, 52803, United States
Central Cardiology Associates
Elizabethtown, Kentucky, 42701, United States
Maine Health
Biddeford, Maine, 04005, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
TidalHealth Peninsula Regional Inc.
Salisbury, Maryland, 21801, United States
Ascension St. Mary's Hospital
Saginaw, Michigan, 48601, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
St. Louis Heart and Vascular
Bridgeton, Missouri, 63044, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
St. Louis University
St Louis, Missouri, 63104, United States
Logan Health Research
Kalispell, Montana, 59901, United States
Virtua Medical Group PA
Marlton, New Jersey, 08053-4197, United States
Raritan Bay Primary and Cardiology Associates
Matawan, New Jersey, 07747, United States
The Heart House
Sewell, New Jersey, 08080, United States
Albany Stratton VA Medical Center
Albany, New York, 12208, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
South Shore University Hospital
Bay Shore, New York, 11706, United States
Focus Clinical Research Solutions
Charlotte, North Carolina, 28204, United States
Nephrology Associates of Greater Cincinnati
Cincinnati, Ohio, 45236, United States
Rama Research LLC
Marion, Ohio, 43302, United States
The Heart and Medical Center
Durant, Oklahoma, 74701, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
East Texas Cardiology PA
Houston, Texas, 77002, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339, United States
Complete Heart Care
McKinney, Texas, 75071, United States
Baylor Scott & White Round Rock
Round Rock, Texas, 78665, United States
Baylor Scott & White Health - Temple
Temple, Texas, 76508, United States
Victoria Heart & Vascular Center
Victoria, Texas, 77901, United States
Richmond Cardiology Associates
Mechanicsville, Virginia, 23116, United States
William S. Middleton Memorial VA Hospital
Madison, Wisconsin, 53705, United States
KH St. Josef Braunau
Braunau am Inn, Austria
LKH Universitatklinikum Graz
Graz, Austria
Ordensklinkum Linz Elisabethinen
Linz, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria
Imed-19 privat
Vienna, Austria
Klinik Floridsdorf
Vienna, Austria
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Grand Hôpital de Charleroi
Charleroi, Belgium
AZ Sint-Blasius
Dendermonde, Belgium
CHU de Liège
Liège, Belgium
AZ Glorieux
Ronse, Belgium
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, Italy
A.O.U. Policlinico di Modena
Modena, Italy
Centro Cardiologico Monzino-IRCCS
Monza, Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, Italy
IRCCS San Raffaele Pisana
Roma, Italy
IRCCS Ospedale Policlinico San Martino
San Martino, Italy
Azienda Servizi Sanitari 1 Triestina
Trieste, Italy
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Juan Ramon Jimenez Hospital
Huelva, Spain
Complejo Hospitalario de Jaen
Jaén, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain
Hospital Universitario Clinico San Carlos
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Puerto Real
Puerto Real, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hosp. Universitari Sant Joan de Reus
Tarragona, Spain
Kantonsspital Aarau AG
Aarau, Switzerland
University Hospital Basel
Basel, Switzerland
Hôpitaux Universitaires de Genève - HUG
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Buckinghamshire Healthcare NHS Trust
Amersham, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Barts Health NHS Trust
London, United Kingdom
King's College Hospital
London, United Kingdom
William Harvey Clinical Research Centre
London, United Kingdom
Royal Victoria Infirmary
Newcastle, NE1 4LP, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Whiston Hospital
Rainhill, United Kingdom
Related Publications (1)
Greene SJ, Sauer AJ, Bohm M, Bozkurt B, Butler J, Cleland JGF, Coats AJS, Desai NR, Grobbee DE, Kelepouris E, Pinto F, Rosano G, Donachie V, Fabien S, Waechter S, Crespo-Leiro MG, Hulsmann M, Kempf T, Pfister O, Pouleur AC, Saxena M, Schulz M, Volterrani M, Anker SD, Kosiborod MN. Management of patients with heart failure at high risk of hyperkalaemia: The CARE-HK in HF registry. Eur J Heart Fail. 2025 Nov;27(11):2410-2421. doi: 10.1002/ejhf.3800. Epub 2025 Aug 11.
PMID: 40788620DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sandra Wächter
Vifor International
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 29, 2021
Study Start
April 19, 2021
Primary Completion
February 29, 2024
Study Completion
August 30, 2024
Last Updated
November 4, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be requested 6 months after the primary publication for the entire prospective observation period. Data will be available 5 years for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.