drugset / Trial / NCT02585843

Mineralocorticoid Receptor Antagonists (MRA) in Heart Failure (HF) and Loop Diuretic Resistance

NCT02585843

Phase 2/3 Completed 20 enrolled Columbia University
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a prospective, single-center, double-blind and randomized placebo controlled trial for evaluation of a 7-day 100mg daily dose of spironolactone on weight loss and resolution of signs and symptoms of congestion in outpatients with acute decompensated heart failure (ADHF). Patients who are not responding to their current loop diuretics will be considered for this study. Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of care in management of heart failure (HF) patients. However, recommended doses of MRAs (spironolactone 25mg/daily or eplerenone 50mg/daily) will not have any impact on signs and symptoms of volume overload. Therefore, the proposed study will aim to show the impact of this outpatient regimen to improve diuresis and possible reduction in hospitalization for further diuretic management in HF patients with signs and symptoms of congestion.

Timeline

Start
2015-11
Primary completion
2017-03-31
Completion
2017-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Spironolactone Small molecule 25 mg Oral
Subject Spironolactone Small molecule 100 mg Oral

Indications