Ertugliflozin in Chronic Heart Failure

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04438213
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ertugliflozin — DRUG
    Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
  • Metolazone — DRUG
    Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
  • Placebo — DRUG
    Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo

Study Details

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.

Key Dates

Start date
Mar 10, 2021
Status verified
Oct 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change from baseline to day 7 of plasma volume by add-on to loop diuretic therapy [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06510
Jeffrey Testani, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Yale School of Medicine· New Haven, CT

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