Sleep apnea treatment study for heart patients cancelled
NCT ID NCT01136122
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to find out if treating obstructive sleep apnea with a CPAP machine could help improve insulin resistance and heart function in people with heart failure. It planned to enroll adults aged 18 to 75 with moderate to severe sleep apnea and reduced heart pumping ability. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Started
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Apr 2010
- Finished
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Oct 2013
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Ohio State University Medical Center
Columbus, Ohio, 43221, United States
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Other studies related to the condition(s) this trial covers.
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