Status:
RECRUITING
Ertugliflozin in Chronic Heart Failure
Lead Sponsor:
Yale University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 i...
Detailed Description
This is a randomized placebo controlled mechanistic study to understand the utility of ertugliflozin in heart failure patients with or without diabetes, compared to both placebo and the active control...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Current use or plan to initiate renal replacement therapy or ultrafiltration
- Significant bladder dysfunction or urinary incontinence
- Inability to comply with the serial urine collection procedures
- Current use of a thiazide or thiazide like diuretics or use within 5 half-lives of the drug, including metolazone
- Current use of a SGLT-2 inhibitor, or in the treating provider's judgement, contraindication to be withdrawn from current use of an SGLT-2 inhibitor
- Prior heart transplant, critical stenotic valvular disease or complex congenital heart
- History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 3 months
- History of or current urosepsis or frequent urinary tract infections
- Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study)
- Pregnancy or breastfeeding
- Appears unlikely or unable to participate in the required study procedures, as assessed by the study PI, study coordinator, or designee (ex: clinically-significant psychiatric, addictive, or neurological disease)
- Inability to give written informed consent or follow study protocol
- Severe peripheral artery disease, previous amputation, or threatened amputation
- Life expectancy \< 3 months
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04438213
Start Date
March 10 2021
End Date
December 30 2025
Last Update
October 8 2025
Active Locations (1)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06510