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

Primary Purpose

Obstructive Sleep Apnea

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring Spironolactone, Positive Airway Pressure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Spironolactone

Placebo

Arm Description

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 and will receive treatment as usual for obstructive sleep apnea.

Outcomes

Primary Outcome Measures

Change in apnea-hypopnea index (AHI)
AHI is obtained from polysomnography studies

Secondary Outcome Measures

Change in minimum oxygen saturation (SaO2)
Oxygen saturation is obtained from polysomnography studies
Change in Inflammatory biomarker
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
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.

Full Information

First Posted
December 11, 2019
Last Updated
April 11, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04205136
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Was on hold due to Covid then we were not able to initiate the funding again after such a long hold and loss of team members.
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Spironolactone, Positive Airway Pressure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
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"]) .
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spironolactone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo and will receive treatment as usual for obstructive sleep apnea.
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects assigned to the placebo group will take one pill for the first 4 weeks and a second pill for the remaining 8 weeks.
Primary Outcome Measure Information:
Title
Change in apnea-hypopnea index (AHI)
Description
AHI is obtained from polysomnography studies
Time Frame
Day 0, Day 84
Secondary Outcome Measure Information:
Title
Change in minimum oxygen saturation (SaO2)
Description
Oxygen saturation is obtained from polysomnography studies
Time Frame
Day 0, Day 84
Title
Change in Inflammatory biomarker
Description
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.
Time Frame
Day 0, Day 84
Title
Change in Diurnal blood pressure
Description
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.
Time Frame
Day 0, Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise O'Brien, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertram Pitt, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Todd Arnedt, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study team does not have plans to actively share data, however, they are open to collaboration following contact with the investigator.

Learn more about this trial

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

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