Ertugliflozin in Chronic Heart Failure
Recruiting · NCT04438213 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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- Current use of a SGLT-2 inhibitor, or in the treating provider's judgement, contraindication to be withdrawn from current use of an SGLT-2 inhibitor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
Where it is running
2 locations listed across 1 US state.
- Yale School of Medicine - New Haven, Connecticut, United States
- Yale School of Medicine - New Haven, Connecticut, United States