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

Completed

Conditions studied: Heart Failure, Hyperkalemia

In brief

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.

Key facts

Study ID

NCT04864795

Run by

Vifor (International) Inc.

People needed

2636

Starts

2021-04-19

Expected to finish

2024-08-30

Last updated by the study team

2024-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UC San Diego Sulpizio Cardiovascular Center — La Jolla, California, United States
• Amicis Research Center — Northridge, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Bethesda Hospital East — Boynton Beach, Florida, United States
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Inpatient Research Clinic, LLC — Hialeah, Florida, United States
• Clearwater Cardiovascular Consultants — Largo, Florida, United States
• D&H National Research Centers — Miami, Florida, United States
• Southwest Florida Research, LLC — Naples, Florida, United States
• Peace River Cardiovascular Center — Port Charlotte, Florida, United States
• Clearwater Cardiovascular and Interventional Consultants — Safety Harbor, Florida, United States
• Florida Cardiology P.A — Winter Park, Florida, United States
• IACT Health — Columbus, Georgia, United States
• Cardiology Care Clinics — Eatonton, Georgia, United States
• NSC Research — Johns Creek, Georgia, United States
• Chicago Medical Research, LLC — Hazel Crest, Illinois, United States
• Prairie Cardiovascular Consultants, Ltd. — Springfield, Illinois, United States
• Cardiovascular Medicine, P.C. — Davenport, Iowa, United States
• Central Cardiology Associates — Elizabethtown, Kentucky, United States
• Maine Health — Biddeford, Maine, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• TidalHealth Peninsula Regional Inc. — Salisbury, Maryland, United States
• Ascension St. Mary's Hospital — Saginaw, Michigan, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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