Home › Heart Failure › NCT04438213
Ertugliflozin in Chronic Heart Failure
Ertugliflozin in Chronic Heart Failure: Cardio-renal and Diuretic Effects
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. A clinical diagnosis of chronic heart failure (either systolic or diastolic) 2. Chronic daily oral loop diuretic dose use 3. eGFR ≥20 mL/min/1.73 m2 4. English speaking participants only 5. Signed informed consent Exclusion Criteria: 1. Current use or plan to initiate renal replacement therapy or ultrafiltration 2. Significant bladder dysfunction or urinary incontinence 3. Inability to comply with the serial urine collection procedures 4. Current use of a thiazide or thiazide like diuretics or use within 5 half-lives of the drug, including metolazone 5. Current use of a SGLT-2 inhibitor, or in the treating provider's judgement, contraindication to be withdrawn from current use of an SGLT-2 inhibitor 6. Prior heart transplant, critical stenotic valvular disease or complex congenital heart 7. 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 8. History of or current urosepsis or frequent urinary tract infections 9. Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study) 10. Pregnancy or breastfeeding 11. 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) 12. Inability to give written informed consent or follow study protocol 13. Severe peripheral artery disease, previous amputation, or threatened amputation 14. Life expectancy \< 3 months
About the study
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.
What is being tested
- Ertugliflozin (drug)
- Metolazone (drug)
- Placebo (drug)
Sponsor: Yale University · Participants: 60 · Started: Mar 10, 2021
Contact the study team
- Veena Rao, PHD · Phone: (203) 737-3571
Official record on ClinicalTrials.gov — NCT04438213
Locations in the U.S.
| Connecticut | Yale School of Medicine, New Haven |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.