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

Last updated: October 31, 2024
Sponsor: Vifor (International) Inc.
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT04864795
HQ-NIS-CHF-07.2020
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult aged ≥18 years at enrolment.

  2. Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.

  3. Patient has at least 1 record of LVEF documented in patient medical record in the 24months prior to signature of informed consent. NOTE: If the proportion of patientswith HFpEF exceeds 20% of the target sample size, enrolment of patients with an LVEF ≥50% may be capped.

  4. Patient treated with ACEi/ARB/ARNi at enrolment.

  5. Patient treated with or a candidate for treatment with MRA per a relevant treatmentguideline (e.g., HF, CKD, resistant hypertension) at enrolment.

  6. Patient at increased risk of hyperkalaemia due to one or more of the following:

  7. Current hyperkalaemia (sK+ >5.0 mEq/l) at enrolment

  8. Record of documented hyperkalaemia (sK+ >5.0 mEq/l) in the 24 months prior tosignature of informed consent

  9. eGFR <45 ml/min/1.73 m2, or CKD Stage ≥3b.

  10. Patient judged by the Investigator to have sufficient cognitive ability toparticipate.

  11. Signed informed consent provided

Exclusion

Exclusion Criteria:

  1. Patient on renal replacement therapy or mechanical circulatory support.

  2. Disease other than HF with expected survival <1 year.

  3. Patient is participating in, or being screened for, an interventional trial, withthe exception of interventional trials relating to SARS-CoV-2.

  4. Patient already found to be intolerant to MRA for reasons other than hyperkalaemiaor renal impairment.

Study Design

Total Participants: 2636
Study Start date:
April 19, 2021
Estimated Completion Date:
August 30, 2024

Study 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

Connect with a study center

  • KH St. Josef Braunau

    Braunau Am Inn,
    Austria

    Site Not Available

  • LKH Universitatklinikum Graz

    Graz,
    Austria

    Site Not Available

  • Ordensklinkum Linz Elisabethinen

    Linz,
    Austria

    Site Not Available

  • Allgemeines Krankenhaus der Stadt Wien

    Wien,
    Austria

    Site Not Available

  • Imed-19 privat

    Wien,
    Austria

    Site Not Available

  • Klinik Floridsdorf

    Wien,
    Austria

    Site Not Available

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels,
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles,
    Belgium

    Site Not Available

  • Grand Hôpital de Charleroi

    Charleroi,
    Belgium

    Site Not Available

  • AZ Sint-Blasius

    Dendermonde,
    Belgium

    Site Not Available

  • CHU de Liège

    Liège,
    Belgium

    Site Not Available

  • AZ Glorieux

    Ronse,
    Belgium

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna,
    Italy

    Site Not Available

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

    Brescia,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Ferrara,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia,
    Italy

    Site Not Available

  • A.O.U. Policlinico di Modena

    Modena,
    Italy

    Site Not Available

  • Centro Cardiologico Monzino-IRCCS

    Monza,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria "Federico II"

    Napoli,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa,
    Italy

    Site Not Available

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia,
    Italy

    Site Not Available

  • IRCCS San Raffaele Pisana

    Roma,
    Italy

    Site Not Available

  • IRCCS Ospedale Policlinico San Martino

    San Martino,
    Italy

    Site Not Available

  • Azienda Servizi Sanitari 1 Triestina

    Triest,
    Italy

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona, Navarra
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona,
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge

    Barcelona,
    Spain

    Site Not Available

  • Hospital clinic de Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada,
    Spain

    Site Not Available

  • Juan Ramon Jimenez Hospital

    Huelva,
    Spain

    Site Not Available

  • Complejo Hospitalario de Jaen

    Jaén,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario A Coruña

    La Coruña,
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas De Gran Canaria,
    Spain

    Site Not Available

  • Hospital Universitario Clinico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid,
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga,
    Spain

    Site Not Available

  • Hospital Universitario Puerto Real

    Puerto Real,
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla,
    Spain

    Site Not Available

  • Hosp. Universitari Sant Joan de Reus

    Tarragona,
    Spain

    Site Not Available

  • Kantonsspital Aarau AG

    Aarau,
    Switzerland

    Site Not Available

  • University Hospital Basel

    Basel,
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève - HUG

    Geneva,
    Switzerland

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois

    Lausanne,
    Switzerland

    Site Not Available

  • Luzerner Kantonsspital

    Luzern,
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen

    Saint Gallen,
    Switzerland

    Site Not Available

  • Buckinghamshire Healthcare NHS Trust

    Amersham,
    United Kingdom

    Site Not Available

  • Bradford Royal Infirmary

    Bradford,
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter,
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    Harrow,
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust

    London,
    United Kingdom

    Site Not Available

  • King's College Hospital

    London,
    United Kingdom

    Site Not Available

  • William Harvey Clinical Research Centre

    London,
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle, NE1 4LP
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth,
    United Kingdom

    Site Not Available

  • Whiston Hospital

    Rainhill,
    United Kingdom

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • UC San Diego Sulpizio Cardiovascular Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Amicis Research Center

    Northridge, California 91324
    United States

    Site Not Available

  • Bridgeport Hospital

    Bridgeport, Connecticut 06610
    United States

    Site Not Available

  • Bethesda Hospital East

    Boynton Beach, Florida 33425
    United States

    Site Not Available

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Inpatient Research Clinic, LLC

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Clearwater Cardiovascular Consultants

    Largo, Florida 33777
    United States

    Site Not Available

  • D&H National Research Centers

    Miami, Florida 33173
    United States

    Site Not Available

  • Southwest Florida Research, LLC

    Naples, Florida 34102-8143
    United States

    Site Not Available

  • Peace River Cardiovascular Center

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Clearwater Cardiovascular and Interventional Consultants

    Safety Harbor, Florida 32695
    United States

    Site Not Available

  • Florida Cardiology P.A

    Winter Park, Florida 32792
    United States

    Site Not Available

  • IACT Health

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Cardiology Care Clinics

    Eatonton, Georgia 31024
    United States

    Site Not Available

  • NSC Research

    Johns Creek, Georgia 30024
    United States

    Site Not Available

  • Chicago Medical Research, LLC

    Hazel Crest, Illinois 60429-2196
    United States

    Site Not Available

  • Prairie Cardiovascular Consultants, Ltd.

    Springfield, Illinois 62701
    United States

    Site Not Available

  • Cardiovascular Medicine, P.C.

    Davenport, Iowa 52803
    United States

    Site Not Available

  • Central Cardiology Associates

    Elizabethtown, Kentucky 42701
    United States

    Site Not Available

  • Maine Health

    Biddeford, Maine 04005
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • TidalHealth Peninsula Regional Inc.

    Salisbury, Maryland 21801
    United States

    Site Not Available

  • Ascension St. Mary's Hospital

    Saginaw, Michigan 48601
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • St. Louis Heart and Vascular

    Bridgeton, Missouri 63044
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • St. Louis University

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Logan Health Research

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Virtua Medical Group PA

    Marlton, New Jersey 08053-4197
    United States

    Site Not Available

  • Raritan Bay Primary and Cardiology Associates

    Matawan, New Jersey 07747
    United States

    Site Not Available

  • The Heart House

    Sewell, New Jersey 08080
    United States

    Site Not Available

  • Albany Stratton VA Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Capital Cardiology Associates

    Albany, New York 12211
    United States

    Site Not Available

  • South Shore University Hospital

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Focus Clinical Research Solutions

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Nephrology Associates of Greater Cincinnati

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Rama Research LLC

    Marion, Ohio 43302
    United States

    Site Not Available

  • The Heart and Medical Center

    Durant, Oklahoma 74701
    United States

    Site Not Available

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77084
    United States

    Site Not Available

  • East Texas Cardiology PA

    Houston, Texas 77002
    United States

    Site Not Available

  • Texas Cardiology Associates of Houston

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Complete Heart Care

    McKinney, Texas 75071
    United States

    Site Not Available

  • Baylor Scott & White Round Rock

    Round Rock, Texas 78665
    United States

    Site Not Available

  • Baylor Scott & White Health - Temple

    Temple, Texas 76508
    United States

    Site Not Available

  • Victoria Heart & Vascular Center

    Victoria, Texas 77901
    United States

    Site Not Available

  • Richmond Cardiology Associates

    Mechanicsville, Virginia 23116
    United States

    Site Not Available

  • William S. Middleton Memorial VA Hospital

    Madison, Wisconsin 53705
    United States

    Site Not Available

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