NCT05553938

Effects of Acute and Chronic Empagliflozin Heart Failure

Renal Mechanistic Effects of Acute and Chronic Empagliflozin in Heart Failure

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 mg	Empagliflozin 10mg
DRUG	Placebo	Empagliflozin matched placebo tablet

Timeline

• Start date: 2023-08-04
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2022-09-26
• Last updated: 2024-12-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study