Empagliflozin and CPAP in Adults With Heart Failure and Obstructive Sleep Apnea.

Sponsor
Medical University of Bialystok
Study ID
NCT07556094
Status
Completed

Conditions

  • Heart Failure
  • Obstructive Sleep Apnea (OSA)
  • Sleep Apnea Syndrome, Obstructive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin was initiated at baseline at a dose of 10 mg once daily, administered orally, in addition to background heart failure therapy, and continued throughout the 6-month study period.
  • Continuous Positive Airway Pressure (CPAP) — DEVICE
    Continuous positive airway pressure therapy was initiated after 3 months in all participants using standard clinical practice. CPAP was applied nightly during sleep, with pressure settings individually titrated. The mean therapeutic pressure was approximately 15.5 ± 2.5 cm H₂O. Treatment was continued until the end of the study.

Study Details

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.

Key Dates

Start date
Jun 5, 2023
Status verified
Apr 2026
Primary completion
May 9, 2025
Completion
May 9, 2025

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin + Background Heart Failure Therapy
    Participants with HF and OSA initiated empagliflozin at baseline in addition to background heart failure therapy and continued treatment throughout the 6-month study period. During the first phase (0-3 months), the effects of empagliflozin were assessed. Continuous positive airway pressure therapy was initiated after 3 months and continued until the end of the study. This design allowed evaluation of the isolated effect of empagliflozin before CPAP initiation and assessment of its influence on response to subsequent CPAP therapy.
  • Active Comparator: Background Heart Failure Therapy Without Empagliflozin
    Participants continued background heart failure therapy without empagliflozin. Continuous positive airway pressure (CPAP) therapy was initiated after 3 months and continued until the end of the study. This design allowed evaluation of the isolated effect of empagliflozin before CPAP initiation and assessment of its influence on response to subsequent CPAP therapy.

Primary Outcome Measure

Change in Apnea-Hypopnea Index (AHI). [ Time Frame: Baseline, 3 months, and 6 months. ]

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