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

Completed

• Conditions: Heart Failure; Hyperkalemia

• Registration Number: NCT04864795
• Lead Sponsor: Vifor (International) Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2021-04-06
• Study Start: 2021-04-19
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-29
• Primary Completion: 2024-02-29
• Status Verified: 2024-04
• Study Completion: 2024-08-30
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2636

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients by RAASi dose modification following hyperkalaemic episodes	at 6-month intervals after a hyperkalaemic episode	RAASi
Percentage of patients by RAASi optimisation	at 6-months intervals	overall
Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic	at 6-months following enrolment	episodes

Secondary Outcome Measures

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

Trial Locations

Locations (115)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

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; 🇺🇸 Largo, Florida, United States

Innovative Research of West Florida, Inc.; 🇺🇸 Clearwater, Florida, United States

Inpatient Research Clinic, LLC; 🇺🇸 Hialeah, Florida, United States

D&H National Research Centers; 🇺🇸 Miami, Florida, United States

Southwest Florida Research, LLC; 🇺🇸 Naples, Florida, United States

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