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NCT05553938 · ClinicalTrials.gov registry record · Phase 1
Effects of Acute and Chronic Empagliflozin Heart Failure
A Phase 1 study of Heart Failure, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT05553938: Recruiting Phase 1 study of Heart Failure, sponsored by Yale University.
NCT05553938 is a Phase 1 study of Heart Failure that is actively recruiting participants, run by Yale University. The registered enrollment target is 60 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05553938, a Phase 1 study of Heart Failure, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The natriuretic effect (urine sodium concentration) of each arm with loop diuretic therapy will be measured by the mmols of sodium excreted on day 1.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Empagliflozin 10 mg
Study Locations (2)
Connecticut
- Yale New Haven Hospital - New Haven
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-08-04 |
| Est. Completion | 2025-11 |
| Phase | Phase 1 |
What NCT05553938 shows while recruiting
NCT05553938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05553938 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05553938 about?
NCT05553938 is a clinical study titled "Effects of Acute and Chronic Empagliflozin Heart Failure". 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 placeb...
What is the current status of trial NCT05553938?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-08-04. Estimated completion is 2025-11.
What conditions does trial NCT05553938 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT05553938?
The interventions under investigation include: Placebo (DRUG), Empagliflozin 10 mg (DRUG).
Who is sponsoring clinical trial NCT05553938?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05553938 being conducted?
This trial has 2 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05553938's enrollment target sits among peer trials
60 254th of 397 higher than 131 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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