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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04438213
The ClinicalTrials.gov registry entry for NCT04438213 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.