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NCT04438213 · ClinicalTrials.gov registry record · Phase 2
Ertugliflozin in Chronic Heart Failure
A Phase 2 study of Heart Failure, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04438213: Recruiting Phase 2 study of Heart Failure, sponsored by Yale University.
NCT04438213 is a Phase 2 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 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04438213, a Phase 2 study of Heart Failure, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the effects on heart failure signs and symptoms of the use of either ertugliflozin, metolazone or placebo, in conjunction with intravenous loop diuretic use in acute settings and chronic oral loop diuretic therapy. There are two general purposes for this study. The proposed study is both larger and more rigorous than essentially all PK/PD studies that form the basis of current practice with loop diuretics as well as all studies looking at add-on thiazide therapy (current guideline-recommended adjuvant). The second is to generate a mechanistic understanding of the pleotropic cardio-renal factors with chronic therapy that differentiate ertugliflozin from traditional diuretics particularly in how they maintain reduced blood volume without the complication of over-diuresis and volume depletion.
Primary Outcome
The primary outcome of the chronic effects of add-on placebo, thiazide-like diuretic, or SGLT2 inhibitor is to determine the change in plasma volume from baseline to day 7
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ertugliflozin
- DRUG Metolazone
Study Locations (1)
Connecticut
- Yale School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 2 |
What NCT04438213 shows while recruiting
NCT04438213 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 3 interventions - of which Placebo is the first listed.
NCT04438213 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04438213 about?
NCT04438213 is a clinical study titled "Ertugliflozin in Chronic Heart Failure". The purpose of this study is to determine the effects on heart failure signs and symptoms of the use of either ertugliflozin, metolazone or placebo, in conjunction with intravenous loop diuretic use in acute settings and chronic oral loop diuretic therapy. There are two general purposes for this st...
What is the current status of trial NCT04438213?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-03-10. Estimated completion is 2025-12-30.
What conditions does trial NCT04438213 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT04438213?
The interventions under investigation include: Placebo (DRUG), Ertugliflozin (DRUG), Metolazone (DRUG).
Who is sponsoring clinical trial NCT04438213?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04438213 being conducted?
This trial has 1 study location 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 NCT04438213'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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