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RECRUITING
NCT04438213
PHASE2

Ertugliflozin in Chronic Heart Failure

Sponsor: Yale University

View on ClinicalTrials.gov

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.

Official title: Ertugliflozin in Chronic Heart Failure: Cardio-renal and Diuretic Effects

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-03-10

Completion Date

2025-12-30

Last Updated

2025-10-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

Ertugliflozin

Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo

DRUG

Metolazone

Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo

DRUG

Placebo

Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo

Locations (1)

Yale School of Medicine

New Haven, Connecticut, United States