Obstructive Sleep Apnea Clinical Trial
— OSA-MRIOfficial title:
Effects of Positive Airway Pressure (PAP) Treatment of Obstructive Sleep Apnea (OSA) in Patients With Heart Failure
NCT number | NCT01136122 |
Other study ID # | 2009H0304 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | May 17, 2010 |
Last updated | March 28, 2016 |
Start date | April 2010 |
Verified date | March 2016 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to see if treatment of OSA with the CPAP device makes a difference to insulin resistance and heart disease.
Status | Terminated |
Enrollment | 3 |
Est. completion date | |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 18 and < 75 years of age. - Apnea-hypopnea index (AHI) of at least 15/hr based on overnight polysomnography. - New York Heart Association Class 3 or less. - LV ejection fraction <45% based on a prior imaging study (as measured within one year of baseline studies). - Absence of exacerbation of heart failure requiring hospitalization within the previous 3 mos. - Optimal pharmacologic therapy at the highest tolerated dose [3]. Exclusion Criteria: - Use of anti-diabetic medications - Primary valvular heart disease - Unstable angina - Myocardial infarction, cardiac surgery, or revascularization procedure within the previous 3 months - Uncontrolled hypertension defined as systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg. - Active smoking (Patient should not have smoked for at least 1 month prior to baseline studies and has the intention not to smoke for the duration of the study period) - Use of illicit drugs - Current use of home oxygen therapy - Requirement for a bi-level machine to treat sleep apnea - Use of corticosteroids - Creatinine clearance < 30ml/min (calculated from serum creatinine) - Pregnant women will be excluded as pregnancy interferes with glucose and adiponectin. Additionally the contrast used in the cardiac MRIs may be harmful to unborn babies. Females of child bearing potential must agree to use effective contraception during the trial. - Any contraindication to CMR (Cardiovascular magnetic resonance) imaging such as ferromagnetic foreign body, orbital metal, cerebral aneurysm clip, pacemaker, defibrillator, neurostimulator, allergy to gadolinium-based contrast, or severe claustrophobia. The standard FDA and OSUMC's screening guidelines for MRI safety will be followed. - Inability or unwillingness to provide consent |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ulysses Magalang MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad. | One month | No | |
Secondary | Increased levels of Ad and/or HMW Ad associate with improvements in insulin sensitivity and heart function in patients with known left ventricular (LV) systolic dysfunction. | One month | No |
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