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

NCT07556094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-29

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Empagliflozin

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.

DEVICE

Continuous Positive Airway Pressure (CPAP)

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.

Sponsors & Collaborators

  • Medical University of Bialystok

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2025-05-09
Completion
2025-05-09

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07556094 on ClinicalTrials.gov