Renal Mechanistic Effects of Acute and Chronic Empagliflozin in Heart Failure

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A clinical diagnosis of worsening heart failure (worsening of congestive symptoms with current therapies) in the opinion of the investigator.

• A planned outpatient diuretic intervention (either up-titration of loop or addition of thiazide diuretic) for worsening heart failure per treating clinician. Diuretic intervention can occur via an unplanned in person visit (e.g., outpatient ambulatory clinic, emergency department, same day access visit) or via a telephone encounter (e.g., patient calling the clinic with reported weight gain and SOB that is prescribed uptitration of diuretic therapy).

• Estimated or reported weight gain of at least 5 lbs.

• Chronic daily oral loop diuretic dose ≥ 20mg furosemide equivalents for at least one month prior to enrollment

• Estimated GFR (eGFR) ≥ 20 mL/min/1.73 m2

• Age ≥ 18 years old

• Signed informed consent

• English speaking participants only

Locations
United States
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Yale University
RECRUITING
New Haven
Contact Information
Primary
Veena Rao, PHD
veena.s.rao@yale.edu
2037373571
Backup
Kara Otis
kara.otis@yale.edu
2037373571
Time Frame
Start Date: 2023-08-04
Estimated Completion Date: 2025-11
Participants
Target number of participants: 60
Treatments
Experimental: Empagliflozin
Empagliflozin 10 mg daily for weeks 1-6
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
Related Therapeutic Areas
Sponsors
Leads: Yale University

This content was sourced from clinicaltrials.gov