Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients
NCT ID: NCT04205136
Last Updated: 2022-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2022-03-31
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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.
Placebo
Placebo and will receive treatment as usual for obstructive sleep apnea.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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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
Principal Investigators
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Louise O'Brien, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Bertram Pitt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
J. Todd Arnedt, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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The University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00147375
Identifier Type: -
Identifier Source: org_study_id
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