NCT04864795

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

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

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

EXCLUSION CRITERIA

Exclusion Criteria:

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.