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Effects of Acute and Chronic Empagliflozin Heart Failure

NCT05553938 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Empagliflozin 10 mg

Empagliflozin 10mg

DRUG

Placebo

Empagliflozin matched placebo tablet

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Jeffrey Testani, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-04
Primary Completion
2025-11-30
Completion
2025-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05553938 on ClinicalTrials.gov