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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Hyperkalemia

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

• Study Type: Observational
• Enrollment (Actual): 2636

Contacts and Locations

• Study Contact: Name: Sandra Wächter; Phone Number: +41 58 851 80 90; Email: sandra.waechter@viforpharma.com

Study Locations

• Austria
  • Braunau Am Inn, Austria
    • KH St. Josef Braunau
  • Graz, Austria
    • LKH Universitatklinikum Graz
  • Linz, Austria
    • Ordensklinkum Linz Elisabethinen
  • Wien, Austria
    • Allgemeines Krankenhaus der Stadt Wien
  • Wien, Austria
    • Klinik Floridsdorf
  • Wien, Austria
    • Imed-19 privat
• Belgium
  • Brussels, Belgium
    • Cliniques Universitaires de Bruxelles Hopital Erasme
  • Bruxelles, Belgium
    • Cliniques universitaires Saint-Luc
  • Charleroi, Belgium
    • Grand Hôpital de Charleroi
  • Dendermonde, Belgium
    • AZ Sint-Blasius
  • Liège, Belgium
    • CHU de Liège
  • Ronse, Belgium
    • AZ Glorieux
• Italy
  • Bologna, Italy
    • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
  • Brescia, Italy
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Ferrara, Italy
    • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
  • Foggia, Italy
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
  • Modena, Italy
    • A.O.U. Policlinico di Modena
  • Monza, Italy
    • Centro Cardiologico Monzino-IRCCS
  • Napoli, Italy
    • Azienda Ospedaliera Universitaria "Federico II"
  • Pisa, Italy
    • Azienda Ospedaliero Universitaria Pisana
  • Reggio Emilia, Italy
    • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
  • Roma, Italy
    • IRCCS San Raffaele Pisana
  • San Martino, Italy
    • IRCCS Ospedale Policlinico San Martino
  • Triest, Italy
    • Azienda Servizi Sanitari 1 Triestina
• Spain
  • Badalona, Spain
    • Hospital Universitari Germans Trias i Pujol
  • Barcelona, Spain
    • Hospital Clinic de Barcelona
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Hospital de la Santa Creu I Sant Pau
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
  • Granada, Spain
    • Hospital Universitario Virgen de las Nieves
  • Huelva, Spain
    • Juan Ramon Jimenez Hospital
  • Jaén, Spain
    • Complejo Hospitalario de Jaen
  • La Coruña, Spain
    • Complejo Hospitalario Universitario A Coruña
  • Las Palmas De Gran Canaria, Spain
    • Hospital Universitario de Gran Canaria Dr. Negrin
  • Madrid, Spain
    • Hospital Universitario Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain
    • Hospital Universitario Infanta Leonor
  • Málaga, Spain
    • Hospital Clinico Universitario Virgen de la Victoria
  • Puerto Real, Spain
    • Hospital Universitario Puerto Real
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocio
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena
  • Tarragona, Spain
    • Hosp. Universitari Sant Joan de Reus
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Madrid
    • Leganés, Madrid, Spain
      • Hospital Universitario Severo Ochoa
    • Majadahonda, Madrid, Spain
      • Hospital Universitario Puerta de Hierro Majadahonda
  • Navarra
    • Pamplona, Navarra, Spain
      • Complejo Hospitalario de Navarra
• Switzerland
  • Aarau, Switzerland
    • Kantonsspital Aarau AG
  • Basel, Switzerland
    • University Hospital Basel
  • Geneva, Switzerland
    • Hopitaux Universitaires de Geneve - HUG
  • Lausanne, Switzerland
    • Centre Hospitalier Universitaire Vaudois
  • Luzern, Switzerland
    • Luzerner Kantonsspital
  • Saint Gallen, Switzerland
    • Kantonsspital St. Gallen
• United Kingdom
  • Amersham, United Kingdom
    • Buckinghamshire Healthcare NHS Trust
  • Bradford, United Kingdom
    • Bradford Royal Infirmary
  • Exeter, United Kingdom
    • Royal Devon and Exeter Hospital (Wonford)
  • Harrow, United Kingdom
    • Northwick Park Hospital
  • Liverpool, United Kingdom
    • Royal Liverpool University Hospital
  • London, United Kingdom
    • Barts Health NHS Trust
  • London, United Kingdom
    • King's College Hospital
  • London, United Kingdom
    • William Harvey Clinical Research Centre
  • Newcastle, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Plymouth, United Kingdom
    • Derriford Hospital
  • Rainhill, United Kingdom
    • Whiston Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego Sulpizio Cardiovascular Center
    • Northridge, California, United States, 91324
      • Amicis Research Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
  • Florida
    • Boynton Beach, Florida, United States, 33425
      • Bethesda Hospital East
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida, Inc.
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular Consultants
    • Hialeah, Florida, United States, 33013
      • Inpatient Research Clinic, LLC
    • Largo, Florida, United States, 33777
      • Clearwater Cardiovascular Consultants
    • Miami, Florida, United States, 33173
      • D&H National Research Centers
    • Naples, Florida, United States, 34102-8143
      • Southwest Florida Research, LLC
    • Port Charlotte, Florida, United States, 33952
      • Peace River Cardiovascular Center
    • Safety Harbor, Florida, United States, 32695
      • Clearwater Cardiovascular and Interventional Consultants
    • Winter Park, Florida, United States, 32792
      • Florida Cardiology P.A
  • Georgia
    • Columbus, Georgia, United States, 31904
      • IACT Health
    • Eatonton, Georgia, United States, 31024
      • Cardiology Care Clinics
    • Johns Creek, Georgia, United States, 30024
      • NSC Research
  • Illinois
    • Hazel Crest, Illinois, United States, 60429-2196
      • Chicago Medical Research, LLC
    • Springfield, Illinois, United States, 62701
      • Prairie Cardiovascular Consultants, Ltd.
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Cardiovascular Medicine, P.C.
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Central Cardiology Associates
  • Maine
    • Biddeford, Maine, United States, 04005
      • Maine Health
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
    • Salisbury, Maryland, United States, 21801
      • TidalHealth Peninsula Regional Inc.
  • Michigan
    • Saginaw, Michigan, United States, 48601
      • Ascension St. Mary's Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • St. Louis Heart and Vascular
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital Of Kansas City
    • Saint Louis, Missouri, United States, 63104
      • St. Louis University
  • Montana
    • Kalispell, Montana, United States, 59901
      • Logan Health Research
  • New Jersey
    • Marlton, New Jersey, United States, 08053-4197
      • Virtua Medical Group PA
    • Matawan, New Jersey, United States, 07747
      • Raritan Bay Primary and Cardiology Associates
    • Sewell, New Jersey, United States, 08080
      • The Heart House
  • New York
    • Albany, New York, United States, 12211
      • Capital Cardiology Associates
    • Albany, New York, United States, 12208
      • Albany Stratton VA Medical Center
    • Bay Shore, New York, United States, 11706
      • South Shore University Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Focus Clinical Research Solutions
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Nephrology Associates of Greater Cincinnati
    • Marion, Ohio, United States, 43302
      • Rama Research LLC
  • Oklahoma
    • Durant, Oklahoma, United States, 74701
      • The Heart and Medical Center
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research, LLC
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77002
      • East Texas Cardiology PA
    • Kingwood, Texas, United States, 77339
      • Texas Cardiology Associates of Houston
    • McKinney, Texas, United States, 75071
      • Complete Heart Care
    • Round Rock, Texas, United States, 78665
      • Baylor Scott & White Round Rock
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Health - Temple
    • Victoria, Texas, United States, 77901
      • Victoria Heart & Vascular Center
  • Virginia
    • Mechanicsville, Virginia, United States, 23116
      • Richmond Cardiology Associates
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • William S. Middleton Memorial VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 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.
4. Patient treated with ACEi/ARB/ARNi at enrolment.
5. Patient treated with or a candidate for treatment with MRA per a relevant treatment guideline (e.g., HF, CKD, resistant hypertension) at enrolment.

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

   1. Current hyperkalaemia (sK+ >5.0 mEq/l) at enrolment
   2. Record of documented hyperkalaemia (sK+ >5.0 mEq/l) in the 24 months prior to signature of informed consent
   3. eGFR <45 ml/min/1.73 m2, or CKD Stage ≥3b.
7. Patient judged by the Investigator to have sufficient cognitive ability to participate.
8. Signed informed consent provided

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, with the exception of interventional trials relating to SARS-CoV-2.
4. Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description and change of disease status measured by patient reported outcome (PRO) by RAASi treatment optimisation	Kansas City Cardiomyopathy Questionnaire (KCCQ)	at enrolment and at approximately 6-months intervals
Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation	RAASi	at 6-months following enrolment
Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment	RAASi	up to 6 months following enrolment

Collaborators and Investigators

• Sponsor: Vifor (International) Inc.
• Investigators: Study Chair: Sandra Wächter, Vifor International

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): February 29, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Estimated): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Water-Electrolyte Imbalance; Heart Failure; Hyperkalemia
• Other Study ID Numbers: HQ-NIS-CHF-07.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing 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.

• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No