Heart Failure Clinical Trial

Effects of Acute and Chronic Empagliflozin 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.

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Full Description

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.

The broad study design aims to evaluate change in gold standard determined body fluid spaces, sodium avidity, and cardio-renal biomarkers longitudinally in patients treated with placebo vs. empagliflozin over a 6 week period. Primary analysis of the randomized intervention will occur during the 6 week double blind period. Crossover of placebo patients to active therapy from 6-12 weeks will provide additional exploratory mechanistic data at low incremental cost and provide added benefit to enrollment of the study.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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)

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05553938

Recruitment Status:

Recruiting

Sponsor:

Yale University

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There is 1 Location for this study

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Yale New Haven Hospital
New Haven Connecticut, 06520, United States
Yale University
New Haven Connecticut, 06520, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05553938

Recruitment Status:

Recruiting

Sponsor:


Yale University

How clear is this clinincal trial information?

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