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Empagliflozin for Worsening Heart Failure

This study is looking at how empagliflozin 10 mg affects people with worsening heart failure. Researchers want to understand if empagliflozin, compared to a placebo (an inactive pill), can help with symptoms like fluid buildup. You might be able to join if you are 18 or older, have worsening heart failure, and your doctor plans to adjust your diuretic (water pill) medication. The study will measure changes in your body's fluid levels and other heart and kidney markers. This study is currently unclear about its recruitment status and plans to enroll 60 participants.

Study design
This is a randomized, double-blind, placebo-controlled study involving 60 participants. Participants will receive either empagliflozin or a placebo for 6 weeks, then those on placebo will switch to empagliflozin for another 6 weeks.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes up to 7 days for some endpoints, and participants receive active treatment for up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05553938

Effects of Acute and Chronic Empagliflozin Heart Failure

Active, Not Recruiting
PHASE1Ages 18+Interventional
Yale University
~60 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Empagliflozin 10 mgPlacebo

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Natriuretic effect of empagliflozin or placebo as an adjuvant to loop diuretic therapy
Measured over Day 1
+2 more outcomes measured

Conditions

Heart Failure

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Heart Failure

NCT05553938

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Yale New Haven Hospital

    New Haven, Connecticutno site contact published

  • Yale University

    New Haven, Connecticutno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeffrey Testani, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Natriuretic effect of empagliflozin or placebo as an adjuvant to loop diuretic therapyDay 1

    The natriuretic effect (urine sodium concentration) of each arm with loop diuretic therapy will be measured by the mmols of sodium excreted on day 1.

  • Change in plasma volume from baseline to 7 daysDay 1 and Day 7

    Chronic effects of empagliflozin or placebo to the loop diuretic will be assessed by measuring the change in plasma volume \[ml\] from Day 1 to Day 7, using I-131 albumin

  • Change in total body water from baseline to 7 daysDay 1 and Day 7

    Chronic effects of empagliflozin or placebo to the loop diuretic will be assessed by measuring the change in total body water \[liters\] from Day 1 to Day 7, using heavy water \[D2O)