Status:
COMPLETED
Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
Lead Sponsor:
Vifor (International) Inc.
Conditions:
Heart Failure
Hyperkalemia
Eligibility:
All Genders
18+ years
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 stud...
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 coll...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
2636 Patients enrolled
Trial Details
Trial ID
NCT04864795
Start Date
April 19 2021
End Date
August 30 2024
Last Update
November 4 2024
Active Locations (116)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, United States, 92037
3
Amicis Research Center
Northridge, California, United States, 91324
4
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610