drugset / Trial / NCT04438213

Ertugliflozin in Chronic Heart Failure

NCT04438213

Phase 2 Recruiting 60 enrolled Yale University Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-03-10
Primary completion
2025-12-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ertugliflozin Unknown
Subject Metolazone Small molecule

Indications