Effects of Acute and Chronic Empagliflozin Heart Failure

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05553938
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 mg — DRUG
    Empagliflozin 10mg
  • Placebo — DRUG
    Empagliflozin matched placebo tablet

Study Details

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.

Key Dates

Start date
Aug 4, 2023
Status verified
Dec 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • 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

Primary Outcome Measure

Natriuretic effect of empagliflozin or placebo as an adjuvant to loop diuretic therapy [ Time Frame: Day 1 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06520-
Yale UniversityNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Yale New Haven Hospital· New Haven, CTYale University· New Haven, CT

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