Effects of PAP Treatment of OSA in Patients With Heart Failure

NCT01136122 | Withdrawn FDA Device

• 1 other identifier: 2009H0304
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad.

  One month

Secondary Outcomes (1)

• 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

Study Arms (2)

CPAP Arm

ACTIVE COMPARATOR

Receive effective CPAP treatment for one month

Device: CPAP Treatment

Control Arm

NO INTERVENTION

Receive no treatment for one month

Interventions

CPAP Treatment DEVICE

Effective CPAP treatment for one month

Also known as: CPAP

CPAP Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ulysses Magalang MD: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ulysses Magalang, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Sleep Medicine-East

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: June 3, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 20, 2025

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)