Clinical trial NCT04205136: Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Spironolactone
Positive Airway Pressure
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The researchers will do a trial of spironolactone in 30 obstructive sleep apnea (OSA) patients with cardiovascular disease who are non-adherent with Positive Airway Pressure (PAP) therapy.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in apnea-hypopnea index (AHI)
timeFrame: Day 0, Day 84
Secondary outcomes:
measure: Change in minimum oxygen saturation (SaO2)
timeFrame: Day 0, Day 84
measure: Change in Inflammatory biomarker
timeFrame: Day 0, Day 84
measure: Change in Diurnal blood pressure
timeFrame: Day 0, Day 84
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Louise O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Bertram Pitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: J. Todd Arnedt, PhD
role: PRINCIPAL_INVESTIGATOR
References: