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Could a diabetes drug help heart failure patients shed excess fluid?

NCT ID NCT05553938

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study investigates whether empagliflozin, a drug typically used for diabetes, can help people with worsening heart failure get rid of extra fluid. Researchers will give 60 participants either empagliflozin or a placebo for six weeks, alongside their usual diuretic medication, and measure how much salt and water their kidneys remove. The goal is to see if empagliflozin improves fluid balance, which could ease symptoms like swelling and shortness of breath.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
empagliflozin
What this could lead to
If successful, this could show that empagliflozin helps heart failure patients get rid of excess fluid more effectively, potentially reducing hospital visits.
What could go wrong
This is an early-phase study with only 60 participants, so results may not apply to all heart failure patients. The drug may not improve fluid removal or could cause side effects like dehydration or kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

60 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

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