RecruitingPhase 1NCT05553938

Effects of Acute and Chronic Empagliflozin Heart Failure

Renal Mechanistic Effects of Acute and Chronic Empagliflozin in Heart Failure

Sponsor

Yale University

Enrollment

60 participants

Start Date

Aug 4, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure

Summary

This is a 60-patient randomized, double-blind, placebo-controlled mechanistic study to understand the utility of empagliflozin in worsening heart failure (HF) patients with or without diabetes. Participants will be randomized to empagliflozin or placebo for 6 weeks, followed by a crossover of placebo patients to active therapy at 6 weeks-12 weeks.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

A clinical diagnosis of worsening heart failure (worsening of congestive symptoms with current therapies) in the opinion of the investigator.
A planned outpatient diuretic intervention (either up-titration of loop or addition of thiazide diuretic) for worsening heart failure per treating clinician. Diuretic intervention can occur via an unplanned in person visit (e.g., outpatient ambulatory clinic, emergency department, same day access visit) or via a telephone encounter (e.g., patient calling the clinic with reported weight gain and SOB that is prescribed uptitration of diuretic therapy).
Estimated or reported weight gain of at least 5 lbs.
Chronic daily oral loop diuretic dose ≥ 20mg furosemide equivalents for at least one month prior to enrollment
Estimated GFR (eGFR) ≥ 20 mL/min/1.73 m2
Age ≥ 18 years old
Signed informed consent
English speaking participants only

Exclusion Criteria11

Need for heart failure hospitalization at the time of randomization
Current use or plan to initiate renal replacement therapy
Significant bladder dysfunction or urinary incontinence
Inability to comply with the serial urine collection procedures
Chronic use of natriuretic doses of thiazide diuretics (≥50mg hydrochlorothiazide or equivalent)
Critical stenotic valvular disease, complex congenital heart disease or prior heart transplant
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 6 months
History of or current urosepsis or frequent urinary tract infections
Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study) or active bleeding
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)