Heart Failure Clinical Trials

Find Heart Failure Clinical Trials Near You

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

Who is this study for? Adult patients with heart failure
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A clinical diagnosis of chronic heart failure (either systolic or diastolic)

• Chronic daily oral loop diuretic dose use

• eGFR ≥20 mL/min/1.73 m2

• English speaking participants only

• Signed informed consent

Locations
United States
Connecticut
Yale School of Medicine
RECRUITING
New Haven
Contact Information
Primary
Veena Rao, PHD
veena.s.rao@yale.edu
(203) 737-3571
Time Frame
Start Date: 2021-03-10
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 60
Treatments
Experimental: Ertugliflozin
Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
Experimental: Metolazone
Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
Placebo_comparator: Placebo
Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Yale University

This content was sourced from clinicaltrials.gov