Effects of PAP Treatment of OSA in Patients With Heart Failure

Withdrawn before enrolling · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT01136122

Run by

Ulysses Magalang MD

People needed

0

Starts

2010-04-01

Expected to finish

2013-10-01

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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].

You may not qualify if…

• 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

Where it is running

• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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