NCT04438213RecruitingPhase 2
Ertugliflozin in Chronic Heart Failure
Ertugliflozin in Chronic Heart Failure: Cardio-renal and Diuretic Effects
Source: ClinicalTrials.gov · Last updated 8 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 3 Jun 2020
- Start date
- 10 Mar 2021
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Yale University
- Diseases
- Heart failure
- NCT number
- NCT04438213
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 10 Mar 2021 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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- Current use of a SGLT-2 inhibitor, or in the treating provider's judgement, contraindication to be withdrawn from current use of an SGLT-2 inhibitor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
Other illness
- 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)
Lab values
- Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale School of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.