Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study
Status:
Withdrawn
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Indiana University
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) Vanderbilt University Wayne State University