Ertugliflozin for treating heart failure symptoms

Ertugliflozin in Chronic Heart Failure: Cardio-renal and Diuretic Effects

This study is testing if a new medication called ertugliflozin can help people with heart failure feel better by managing their fluid levels while they are in the hospital and after they go home.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT04438213 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of ertugliflozin, metolazone, and placebo on heart failure symptoms in patients receiving intravenous loop diuretics. It is a randomized, placebo-controlled trial designed to assess changes in body fluid spaces and other cardio-renal factors in acute and post-acute heart failure patients. The study aims to provide a mechanistic understanding of how ertugliflozin differs from traditional diuretics in managing fluid volume without causing over-diuresis. Participants will receive treatment for a total of six weeks, starting during their hospital stay and continuing after discharge.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with acute decompensated heart failure who require intravenous diuretics and have a history of chronic oral loop diuretic use.

Not a fit: Patients currently on renal replacement therapy, those with significant bladder dysfunction, or those unable to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve heart failure management by providing a new treatment option that effectively reduces fluid overload without the risks associated with traditional diuretics.

How similar studies have performed: While there have been studies on diuretics in heart failure, the specific use of ertugliflozin in this context is novel and has not been extensively tested.

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

Where this trial is running

New Haven, Connecticut

• Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Principal investigator: Jeffrey Testani, MD — Yale University
• Study coordinator: Veena Rao, PHD

Conditions Heart Failure; Ertugliflozin; Metolazone