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.