drugset / Trial / NCT02299726

Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study

NCT02299726

RandomizedSingle-groupQuadruple-blindTreatment

Summary

Over one million hospitalizations for acute heart failure (AHF) occur over every year in the United States, resulting in high mortality, re-hospitalizations, and incurred financial costs; yet nearly every attempt over the last 10 years to improve outcomes with novel therapies have all failed. In this proposal, we will study whether a generic drug known as a mineralocorticoid receptor antagonist (more commonly known as an aldosterone blocker), proven to reduce morbidity and mortality for chronic heart failure patients, is safe and feasible to give to AHF patients in the emergency department and during hospitalization for a total of 3 days. The results of this study will provide necessary and sufficient data to design an efficacy study in a larger population to test whether early use of a high-dose of mineralocorticoid receptor antagonists will reduce post-discharge morbidity and mortality.

Timeline

Start
2015-05
Primary completion
2018-05
Completion
2018-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Spironolactone Small molecule 100 mg Oral

Indications