Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
About the study
Who can take part
INCLUSION CRITERIA
Inclusion Criteria:
Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.
Patient has at least 1 record of left ventricular ejection fraction (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 angiotensin-converting enzyme inhibitors (ACEi) / angiotensin receptor blockers (ARB) / angiotensin receptor-neprilysin inhibitors (ARNi) at enrolment.
- Patient treated with or a candidate for treatment with mineralcorticoid receptor antagonist (MRA) per a relevant treatment guideline 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
- estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2, or Chronic Kidney Disease (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.
Study Locations
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How to Apply
Study’s details
Contition
Heart Failure,Hyperkalemia
Age (in years)
18+
Participants needed
2000
Est. Completion Date
May 31, 2025
Treatment type
Observational [Patient Registry]
Sponsor
Vifor Pharma
ClinicalTrials.gov identifier
NCT04864795
Study number
HQ-NIS-CHF-07.2020
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