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Heart failure and sleep apnea: can a drug and breathing machine improve both?

NCT ID NCT07556094

Disease control Sponsor: Medical University of Bialystok Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a diabetes drug called empagliflozin, combined with a breathing machine (CPAP), can improve sleep and heart function in 70 adults with both heart failure and obstructive sleep apnea. Participants were randomly assigned to take empagliflozin or not, and all started CPAP after 3 months. The goal was to see if the drug reduces sleep apnea severity and helps the heart, while also checking how well CPAP works after the drug.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

70 people

The number who actually took part.

Started

Jun 2023

Finished

May 2025

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: * Age ≥18 years * Diagnosed heart failure (HF) on stable guideline-directed medical therapy * Obstructive sleep apnea (OSA) confirmed by sleep study (mild, moderate, or severe) * No prior treatment with empagliflozin or other sodium-glucose cotransporter-2 inhibitors * No prior treatment with continuous positive airway pressure therapy * Body mass index (BMI) \<40 kg/m² * Clinical eligibility for CPAP therapy according to current recommendations * Ability to provide written informed consent Exclusion Criteria: * Age \<18 years * Body mass index (BMI) ≥40 kg/m² * Active malignancy * Severe renal impairment (estimated glomerular filtration rate \<25 mL/min/1.73 m²) * Advanced hepatic insufficiency * Symptomatic hypotension * Clinically significant volume depletion or dehydration * Known hypersensitivity to empagliflozin or any component of the study medication * Any condition that, in the opinion of the investigator, could interfere with study participation or interpretation of results

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Conditions

The condition(s) this trial relates to.

Apnea heart failure obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Heart failure Obstructive sleep apnea (OSA) Sleep apnea syndrome, obstructive

Contacts and locations

Locations

  • University Clinical Hospital in Białystok

    Bialystok, Podlaskie Voivodeship, 15-276, Poland

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