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

NCT04205136 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: HUM00147375
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Spironolactone; Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• Change in apnea-hypopnea index (AHI)

  AHI is obtained from polysomnography studies

  Day 0, Day 84

Secondary Outcomes (3)

• 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

Study Arms (2)

Spironolactone

EXPERIMENTAL

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.

Drug: Spironolactone

Placebo

PLACEBO COMPARATOR

Placebo and will receive treatment as usual for obstructive sleep apnea.

Drug: Placebo

Interventions

Spironolactone DRUG

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.

Spironolactone

Placebo DRUG

Subjects assigned to the placebo group will take one pill for the first 4 weeks and a second pill for the remaining 8 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Louise O'Brien, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Bertram Pitt, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• J. Todd Arnedt, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both groups will receive treatment as usual for obstructive sleep apnea. Spironolactone and placebo will be prescribed by one of the study physicians (who will not be blinded to treatment condition \["care provider"\]) .
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 19, 2019
• Study Start: March 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)