Status:
WITHDRAWN
Effects of PAP Treatment of OSA in Patients With Heart Failure
Lead Sponsor:
Ulysses Magalang MD
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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.
Detailed Description
Obstructive Sleep Apnea (OSA) has been seen frequently in persons who develop insulin resistance and heart disease. Insulin resistance is a condition in which the body produces insulin but does not us...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01136122
Start Date
April 1 2010
End Date
October 1 2013
Last Update
October 20 2025
Active Locations (1)
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1
The Ohio State University Medical Center
Columbus, Ohio, United States, 43221