Swedish Cardiac And Renal Failure study-1 (SCARF-1): An open-label pilot trial to evaluate the feasibility, safety and efficacy of eplerenone in patients with heart failure with reduced ejection fraction and severe chronic kidney disease.

Heart failure with reduced ejection fraction in combination with severe chronic kidney disease

The primary endpoint is the proportion of subjects who complete the entire treatment period with and without the need to use a potassium binder.

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score, Change in six-minute walk distance (6MWD), Change in N-terminal pro b-type natriuretic peptide (NTpro-BNP), Change in eGFR and urine-albumin-creatinine-ratio (UACR), Safety endpoint: The occurrence of plasma potassium (P-K) ≥ 5.5 and ≥ 6.0, Safety endpoint: Hospitalization for hyperkalemia, Safety endpoint: The occurrence of P-K < 3.0, Safety endpoint: Hospitalization for hypokalemia, Safety endpoint: Decrease in eGFR of ≥ 30% and ≥ 50%, Safety endpoint: Hospitalization for renal failure, Safety endpoint: Initiation of dialysis, Safety endpoint: Subject-reported syncope, Safety endpoint: Subject-reported lightheadedness due to orthostatic hypotension as judged by the investigator, Safety endpoint: Any subject-reported side effect, Safety endpoint: Hospitalization for HF, Safety endpoint: All cause hospitalization, Safety endpoint: Cardiovascular (CV) death, Safety endpoint: All cause death

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