Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients With Cardiovascular Disease Who Are Non-Adherent With Positive Airway Pressure: A Randomized Placebo-Controlled Pilot Trial
Overview
- Phase
- Phase 4
- Intervention
- Spironolactone
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- University of Michigan
- Locations
- 1
- Primary Endpoint
- Change in apnea-hypopnea index (AHI)
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to test whether Spironolactone can improve the severity of obstructive sleep apnea and improve cardiovascular biomarkers in people who are not regularly using their Positive Airway Pressure (PAP) therapy.
Investigators
Louise O'Brien
Research Associate Professor, Neurology, Research Associate Professor, Obstetrics and Gynecology, Medical School and Associate Research Scientist, Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Body Mass Index (BMI) greater than or equal to 30
- •Diagnosis of moderate to severe OSA via diagnostic polysomnography (AHI≥15) or home sleep apnea test (respiratory event index (REI)≥15).
- •Diagnosis of cardiovascular disease
- •Meet criteria for hypertension (minimum systolic blood pressure ≥ 140 but \<180)
- •Prescribed PAP therapy but non-adherent (failure to use PAP for at least 4 hours per night on minimum 5/7 nights per week on average over a one-month period)
Exclusion Criteria
- •Diagnosis of congestive heart failure; resistant hypertension; hepatic disease; Addison's disease; cancer; or recent (past 3 months) myocardial infarction, or stroke
- •Diagnosis of central sleep apnea
- •Patients who are not using PAP at all (untreated) or using another form of treatment for OSA
- •Currently taking, recent trial (past month), or allergy for spironolactone
- •Severe respiratory disease (e.g., diagnosis of chronic obstructive pulmonary disease, uncontrolled asthma)
- •History of leukopenia and/or thrombocytopenia
- •Current use of another potassium sparing diuretic (e.g., amiloride or eplerenone)
- •Current use of lithium, barbiturates, narcotics, muscle relaxants, pressor amines, or cholestyramine
- •Patients who plan to have surgery during the time period of the study
Arms & Interventions
Spironolactone
Dose of 25 mg daily that may be titrated up to 50 mg daily, if tolerated and will receive treatment as usual for obstructive sleep apnea.
Intervention: Spironolactone
Placebo
Placebo and will receive treatment as usual for obstructive sleep apnea.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in apnea-hypopnea index (AHI)
Time Frame: Day 0, Day 84
AHI is obtained from polysomnography studies
Secondary Outcomes
- Change in minimum oxygen saturation (SaO2)(Day 0, Day 84)
- Change in Inflammatory biomarker(Day 0, Day 84)
- Change in Diurnal blood pressure(Day 0, Day 84)