Effects of Acute and Chronic Empagliflozin Heart Failure — EMPA HF  

Heart Failure Clinical Trial

Official title: Renal Mechanistic Effects of Acute and Chronic Empagliflozin in Heart Failure

Status Recruiting

Clinical Trial Summary

This is a 60-patient randomized, double-blind, placebo-controlled mechanistic study to understand the utility of empagliflozin in worsening heart failure (HF) patients with or without diabetes. Participants will be randomized to empagliflozin or placebo for 6 weeks, followed by a crossover of placebo patients to active therapy at 6 weeks-12 weeks.

Clinical Trial Description

This is a 60-patient randomized, double-blind, placebo-controlled mechanistic study to understand the utility of empagliflozin in worsening heart failure (HF) patients with or without diabetes.

The broad study design aims to evaluate change in gold standard determined body fluid spaces, sodium avidity, and cardio-renal biomarkers longitudinally in patients treated with placebo vs. empagliflozin over a 6 week period. Primary analysis of the randomized intervention will occur during the 6 week double blind period. Crossover of placebo patients to active therapy from 6-12 weeks will provide additional exploratory mechanistic data at low incremental cost and provide added benefit to enrollment of the study. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT05553938
• Study type: Interventional
• Source: Yale University
• Contact: Veena Rao, PHD
• Phone: 2037373571
• Email: veena.s.rao@yale.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: August 4, 2023
• Completion date: November 2024