Actively Recruiting
Ertugliflozin in Chronic Heart Failure
Led by Yale University · Updated on 2025-10-08
60
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ertugliflozin in Chronic Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of chronic heart failure (systolic or diastolic)
- Use of chronic daily oral loop diuretic medication
- Estimated glomerular filtration rate (eGFR) of 20 mL/min/1.73 m2 or higher
- English speaking
- Signed informed consent
You will not qualify if you...
- Current use or planned start of renal replacement therapy or ultrafiltration
- Significant bladder problems or urinary incontinence
- Unable to comply with serial urine collection procedures
- Current or recent (within 5 half-lives) use of thiazide or thiazide-like diuretics, including metolazone
- Current use of SGLT-2 inhibitors or contraindication to stopping them
- History of heart transplant, severe valve disease, or complex congenital heart disease
- History of type 1 diabetes, diabetic ketoacidosis, brittle diabetes, or severe hypoglycemia requiring emergency care within 3 months
- History or current urosepsis or frequent urinary tract infections
- Anemia with hemoglobin less than 8 g/dL
- Pregnancy or breastfeeding
- Unable or unlikely to participate due to psychiatric, addictive, neurological disease, or other reasons
- Unable to provide written informed consent or follow study protocol
- Severe peripheral artery disease, previous or threatened amputation
- Life expectancy less than 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
V
Veena Rao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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