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Ertugliflozin in Chronic Heart Failure

NCT04438213 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-08

No results posted yet for this 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

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

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Testani, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438213 on ClinicalTrials.gov