Yale University
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.
Heart Failure
Empagliflozin 10 mg
Placebo
Phase 1
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 60 participants |
Masking : | Triple |
Masking Description : | Double-blind |
Primary Purpose : | Other |
Official Title : | Renal Mechanistic Effects of Acute and Chronic Empagliflozin in Heart Failure |
Actual Study Start Date : | August 4, 2023 |
Estimated Primary Completion Date : | November 2024 |
Estimated Study Completion Date : | November 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Empagliflozin Empagliflozin 10 mg daily for weeks 1-6 |
Drug: Empagliflozin 10 mg |
Experimental: Placebo, Then Empagliflozin Participants first receive matching placebo daily for weeks 1-6, then will receive Empagliflozin 10 mg daily for weeks 7-12 |
Drug: Empagliflozin 10 mg |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Recruiting
Yale University
New Haven, Connecticut, United States, 06520