Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients

Phase 4

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Spironolactone; Drug: Placebo

• Registration Number: NCT04205136
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2022-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-19
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spironolactone	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.
Placebo	Placebo	Placebo and will receive treatment as usual for obstructive sleep apnea.

Primary Outcome Measures

Name	Time	Method
Change in apnea-hypopnea index (AHI)	Day 0, Day 84	AHI is obtained from polysomnography studies

Secondary Outcome Measures

Name	Time	Method
Change in minimum oxygen saturation (SaO2)	Day 0, Day 84	Oxygen saturation is obtained from polysomnography studies
Change in Inflammatory biomarker	Day 0, Day 84	Biomarkers of interest will be obtained via blood draws. Markers of interest: Interleukin 6 protein (IL-6), Tumor necrosis factor alpha (TNF α), High Sensitivity C-Reactive Protein, Brain Natriuretic Peptide (BNP), and procollagen 1 and 3.
Change in Diurnal blood pressure	Day 0, Day 84	Measured using SPRINT methods; Seated blood pressure is measured after a rest period using an automated device or manual devices if necessary. The preferred method is the automated device. Both systolic and diastolic blood pressure will be measured.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States