Ertugliflozin in Chronic Heart Failure

Heart Failure Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a randomized placebo controlled mechanistic study to understand the utility of ertugliflozin in acute and post-acute hospitalized heart failure patients with or without diabetes, compared to both placebo and the active control metolazone. The broad study design will be designed around evaluation of change in gold standard determined body fluid spaces (blood volume, extracellular fluid, total body water), administering a sodium chloride challenge, and collecting the necessary biospecimens to test our hypotheses. The general study design will randomize to ertugliflozin vs. placebo early during IV diuretic therapy with continuation post discharge for a total therapy of 6 weeks. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT04438213
• Study type: Interventional
• Source: Yale University
• Contact: Veena Rao, PHD
• Phone: (203) 737-3571
• Email: veena.s.rao@yale.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: March 10, 2021
• Completion date: July 2025