NCT04205136

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Spironolactone	If tolerated and serum potassium \<5.0 meq/L, the dose will be increased to 50 mg (2 pills) after 4 weeks. If serum potassium is \>5.0 but less than 5.5 or creatinine \>4.0 mg/dL, the dose will be adjusted to 25 mg every other day; if potassium levels ≥5.5 in a non-hemolyzed blood sample, the medication will be discontinued.
DRUG	Placebo	Subjects assigned to the placebo group will take one pill for the first 4 weeks and a second pill for the remaining 8 weeks.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2019-12-19
• Last updated: 2022-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study