NCT07556094Completed
Empagliflozin and CPAP in Adults With Heart Failure and Obstructive Sleep Apnea.
Effects of Empagliflozin and Continuous Positive Airway Pressure on Sleep, Cardiac Function, Oxidative Stress Markers, and Patient-Reported Outcomes in Adults With Heart Failure and Obstructive Sleep Apnea: A Randomized Controlled Clinical Trial.
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
The goal of this randomized clinical trial was to evaluate the effects of empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i) on sleep and cardiac outcomes in adults with heart failure (HF) and obstructive sleep apnea syndrome (OSA). The study also examined how subsequent initiation of continuous positive airway pressure (CPAP) therapy affected sleep and cardiac outcomes, and whether response to treatment differed according to baseline obstructive sleep apnea severity. The main questions it aims to answer were: * Does empagliflozin affect sleep apnea severity and nocturnal oxygenation before CPAP initiation? * Does prior empagliflozin treatment influence the response to subsequent CPAP therapy? * Does empagliflozin affect oxidative stress markers, including total oxidative status (TOS), total antioxidant status (TAS), and oxidative stress index (OSI)? * Does CPAP therapy initiation affect cardiac outcomes in both groups? * Does response to treatment differ according to baseline obstructive sleep apnea severity, including mild, moderate, and severe disease? Researchers compared participants receiving empagliflozin in addition to background HF therapy with those continuing background HF therapy without empagliflozin to evaluate the effects of empagliflozin. Participants: * Were randomly assigned to receive empagliflozin plus background HF pharmacotherapy or background HF pharmacotherapy therapy without empagliflozin * Underwent sleep studies, transthoracic echocardiography and clinical assessments at baseline, 3 months, and 6 months. * Provided blood samples for measurement of cardiac biomarkers and oxidative stress markers. * Completed standardized questionnaires assessing sleep quality and symptoms. * Initiated CPAP therapy after 3 months and continued treatment until the end of the study.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 15 Apr 2026
- Start date
- 5 Jun 2023
- Primary completion date
- 9 May 2025
- Lead sponsor
- Medical University of Bialystok
- Diseases
- Heart failure
- NCT number
- NCT07556094
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 5 Jun 2023 to the primary completion date, 9 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active malignancy
- Severe renal impairment (estimated glomerular filtration rate \<25 mL/min/1.73 m²)
- Advanced hepatic insufficiency
- 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
Age
- Age \<18 years
Other
- Body mass index (BMI) ≥40 kg/m²
- Symptomatic hypotension
- Clinically significant volume depletion or dehydration
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinical Hospital in Białystok Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.