Testing ertugliflozin with diuretics for chronic heart failure
Studies ertugliflozin, metolazone or placebo alongside diuretics in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Ertugliflozin in Chronic Heart Failure
Key facts
- Where
- New Haven, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Yale School of MedicineNew Haven, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yale University
- Trial code
- NCT04438213
- Record updated
- 8 October 2025
- Original description
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.Read full original descriptionShow less
Ertugliflozin in Chronic Heart Failure: Cardio-renal and Diuretic Effects
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.
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; 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metolazone; Current use of a SGLT-2 inhibitor, or in the treating provider's judgement, contraindication to be withdrawn from current use of an SGLT-2 inhibitor; Prior heart transplant, critical stenotic valvular disease or complex congenital heart; Severe peripheral artery disease, previous amputation, or threatened amputation; 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; 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); Anemia with hemoglobin <8g/dL (due to required phlebotomy for the study); Significant bladder dysfunction or urinary incontinence; Inability to comply with the serial urine collection procedures; Pregnancy or breastfeeding; Inability to give written informed consent or follow study protocol; Life expectancy < 3 months.