Effects of PAP Treatment of OSA in Patients With Heart Failure (OSA-MRI)

Effects of Positive Airway Pressure (PAP) Treatment of Obstructive Sleep Apnea (OSA) in Patients With Heart Failure

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.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: CPAP Treatment

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 use it properly. Insulin helps the body use glucose for energy. Insulin resistance increases the chance of developing type II diabetes and heart disease.

One method of treatment for OSA is with continuous positive airway pressure (CPAP). This treatment is given by a device named CPAP. There are many different types of CPAPs available on the market that are FDA approved.

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. This study will measure insulin resistance by testing the glucose level in the blood, and testing the levels of special protein found in blood, that are known to increase the sensitivity to insulin and decrease progression of heart disease. The heart disease will be measured by cardiac MRI. Glucose testing and cardiac MRI's are normal testing procedures for people who have OSA and heart disease, however will be conducted more frequently than normal and therefore are for research purposes. The specialized blood testing is for research purposes only.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CPAP Arm; Receive effective CPAP treatment for one month	Device: CPAP Treatment; Effective CPAP treatment for one month; Other Names: CPAP
No Intervention: Control Arm; Receive no treatment for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad.	One month

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ulysses Magalang MD
• Investigators: Principal Investigator: Ulysses Magalang, M.D., Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimated): June 3, 2010

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Therapeutics; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Continuous Positive Airway Pressure
• Other Study ID Numbers: 2009H0304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No