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Heart FailureCARE-HKNCT04864795

Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia

An observational study of Heart Failure and Hyperkalemia, run by Vifor (International) Inc. at 116 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Hyperkalemia
How many people
2,636 participants
Where
116 sitesin 7 countries
Study dates
19 Apr 2021to 30 Aug 2024
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

116 sites in 7 countries.

116 sites in 7 countries

United States52 sites

  • Albany Stratton VA Medical Center

    Albany, New York, 12208

  • Capital Cardiology Associates

    Albany, New York, 12211

  • Johns Hopkins University

    Baltimore, Maryland, 21218

  • South Shore University Hospital

    Bay Shore, New York, 11706

  • Maine Health

    Biddeford, Maine, 04005

  • Bethesda Hospital East

    Boynton Beach, Florida, 33425

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • St. Louis Heart and Vascular

    Bridgeton, Missouri, 63044

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Focus Clinical Research Solutions

    Charlotte, North Carolina, 28204

  • Nephrology Associates of Greater Cincinnati

    Cincinnati, Ohio, 45236

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • IACT Health

    Columbus, Georgia, 31904

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Cardiovascular Medicine, P.C.

    Davenport, Iowa, 52803

  • The Heart and Medical Center

    Durant, Oklahoma, 74701

  • Cardiology Care Clinics

    Eatonton, Georgia, 31024

  • Central Cardiology Associates

    Elizabethtown, Kentucky, 42701

  • Chicago Medical Research, LLC

    Hazel Crest, Illinois, 60429-2196

  • Inpatient Research Clinic, LLC

    Hialeah, Florida, 33013

  • East Texas Cardiology PA

    Houston, Texas, 77002

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • NSC Research

    Johns Creek, Georgia, 30024

  • Logan Health Research

    Kalispell, Montana, 59901

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Texas Cardiology Associates of Houston

    Kingwood, Texas, 77339

  • UC San Diego Sulpizio Cardiovascular Center

    La Jolla, California, 92037

  • Clearwater Cardiovascular Consultants

    Largo, Florida, 33777

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • William S. Middleton Memorial VA Hospital

    Madison, Wisconsin, 53705

  • Rama Research LLC

    Marion, Ohio, 43302

  • Virtua Medical Group PA

    Marlton, New Jersey, 08053-4197

  • Raritan Bay Primary and Cardiology Associates

    Matawan, New Jersey, 07747

  • Complete Heart Care

    McKinney, Texas, 75071

  • Richmond Cardiology Associates

    Mechanicsville, Virginia, 23116

  • D&H National Research Centers

    Miami, Florida, 33173

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Southwest Florida Research, LLC

    Naples, Florida, 34102-8143

  • Amicis Research Center

    Northridge, California, 91324

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Peace River Cardiovascular Center

    Port Charlotte, Florida, 33952

  • Baylor Scott & White Round Rock

    Round Rock, Texas, 78665

  • Clearwater Cardiovascular and Interventional Consultants

    Safety Harbor, Florida, 32695

  • Ascension St. Mary's Hospital

    Saginaw, Michigan, 48601

  • TidalHealth Peninsula Regional Inc.

    Salisbury, Maryland, 21801

  • The Heart House

    Sewell, New Jersey, 08080

  • Prairie Cardiovascular Consultants, Ltd.

    Springfield, Illinois, 62701

  • St. Louis University

    St Louis, Missouri, 63104

  • Baylor Scott & White Health - Temple

    Temple, Texas, 76508

  • Victoria Heart & Vascular Center

    Victoria, Texas, 77901

  • Florida Cardiology P.A

    Winter Park, Florida, 32792

Other trials in United States

Spain23 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña

  • Hospital Universitari Germans Trias i Pujol

    Badalona

  • Hospital clinic de Barcelona

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario Virgen de las Nieves

    Granada

  • Juan Ramon Jimenez Hospital

    Huelva

  • Complejo Hospitalario de Jaen

    Jaén

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid

  • Hospital Universitario Clinico San Carlos

    Madrid

  • Hospital Universitario Infanta Leonor

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre

  • Hospital Universitario Puerto Real

    Puerto Real

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitario Virgen Macarena

    Seville

  • Hosp. Universitari Sant Joan de Reus

    Tarragona

Other trials in Spain

Italy12 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Ferrara

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia

  • A.O.U. Policlinico di Modena

    Modena

  • Centro Cardiologico Monzino-IRCCS

    Monza

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia

  • IRCCS San Raffaele Pisana

    Roma

  • IRCCS Ospedale Policlinico San Martino

    San Martino

  • Azienda Servizi Sanitari 1 Triestina

    Trieste

Other trials in Italy

United Kingdom11 sites

  • Buckinghamshire Healthcare NHS Trust

    Amersham

  • Bradford Royal Infirmary

    Bradford

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter

  • Northwick Park Hospital

    Harrow

  • Royal Liverpool University Hospital

    Liverpool

  • Barts Health NHS Trust

    London

  • King's College Hospital

    London

  • William Harvey Clinical Research Centre

    London

  • Royal Victoria Infirmary

    Newcastle, NE1 4LP

  • Derriford Hospital

    Plymouth

  • Whiston Hospital

    Rainhill

Other trials in United Kingdom

Austria6 sites

  • KH St. Josef Braunau

    Braunau am Inn

  • LKH Universitatklinikum Graz

    Graz

  • Ordensklinkum Linz Elisabethinen

    Linz

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna

  • Imed-19 privat

    Vienna

  • Klinik Floridsdorf

    Vienna

Other trials in Austria

Belgium6 sites

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Grand Hôpital de Charleroi

    Charleroi

  • AZ Sint-Blasius

    Dendermonde

  • CHU de Liège

    Liège

  • AZ Glorieux

    Ronse

Other trials in Belgium

Switzerland6 sites

  • Kantonsspital Aarau AG

    Aarau

  • University Hospital Basel

    Basel

  • Hôpitaux Universitaires de Genève - HUG

    Geneva

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

  • Luzerner Kantonsspital

    Lucerne

  • Kantonsspital St. Gallen

    Sankt Gallen

Other trials in Switzerland

About this study

Official title: Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia (CARE-HK in HF Registry)

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.

Read the detailed description

The study will have an enrolment period of approximately 24 months, and each patient will be followed prospectively for at least 6 months. Each patient is expected to contribute to the study data collection until study end or until premature discontinuation, whichever occurs first (i.e., due to death, withdrawal of consent, or lost to follow-up).

At enrolment (informed consent signed by patient), relevant patient data will be retrospectively extracted from medical records for the 24 months prior to enrolment or since the time of HF diagnosis.

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 and will be entered into the electronic Case Report Form (eCRF) via an electronic data capture (EDC) system. This will include treatments prescribed, routine assessments and measurements (e.g., laboratory parameters) collected at routine clinical visits, as well as hospitalisations and other relevant patient data. Protocol version 3.0, 19-Jul-2023

Medical subject headings
Heart Failure, Hyperkalemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04864795
Study groupRoleWhat they receive
Single CohortPatient 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients by RAASi optimisation

    overall

    Measured: at 6-months intervals

  2. Percentage of patients by RAASi dose modification following hyperkalaemic episodes

    RAASi

    Measured: at 6-month intervals after a hyperkalaemic episode

  3. Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic

    episodes

    Measured: at 6-months following enrolment

Secondary outcomes (3)

  1. Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation

    RAASi

    Measured: at 6-months following enrolment

  2. Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment

    RAASi

    Measured: up to 6 months following enrolment

  3. Description and change of disease status measured by patient reported outcome (PRO) by RAASi treatment optimisation

    Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Measured: at enrolment and at approximately 6-months intervals

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study start19 Apr 2021
  3. Primary completion29 Feb 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,636 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04864795
Sponsor's protocol ID
HQ-NIS-CHF-07.2020
Acronym
CARE-HK
Status last verified
Apr 2024
First submitted
6 Apr 2021
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 40788620

  • Greene SJ, Bohm M, Bozkurt B, Butler J, Cleland JGF, Coats AJS, Desai NR, Grobbee DE, Kelepouris E, Pinto F, Rosano G, Morin I, Szecsody P, Fabien S, Waechter S, Crespo-Leiro MG, Hulsmann M, Kempf T, Pfister O, Pouleur AC, Sauer AJ, Saxena M, Schulz M, Volterrani M, Anker SD, Kosiborod MN. Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalemia or High Risk of Hyperkalemia: Rationale and Design of the CARE-HK in HF Registry. J Card Fail. 2025 Jun;31(6):881-891. doi: 10.1016/j.cardfail.2024.08.048. Epub 2024 Sep 12.

    PubMed 39277029

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Hyperkalemia, run by Vifor (International) Inc. at 116 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Spain, Italy, United Kingdom, Austria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients by RAASi optimisation (time frame: at 6-months intervals). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04864795, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.

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