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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136122
Recruitment Status : Terminated (The study was stopped due to low recruitment.)
First Posted : June 3, 2010
Last Update Posted : April 4, 2016
Information provided by (Responsible Party):
Ulysses Magalang MD, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: CPAP Treatment Phase 1

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  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Effects of Positive Airway Pressure (PAP) Treatment of Obstructive Sleep Apnea (OSA) in Patients With Heart Failure
Study Start Date : April 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: CPAP Arm
Receive effective CPAP treatment for one month
Device: CPAP Treatment
Effective CPAP treatment for one month
Other Name: CPAP

No Intervention: Control Arm
Receive no treatment for one month

Primary Outcome Measures :
  1. Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad. [ Time Frame: One month ]

Secondary Outcome Measures :
  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. [ Time Frame: One month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136122

United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Ulysses Magalang MD
Principal Investigator: Ulysses Magalang, M.D. Ohio State University

Responsible Party: Ulysses Magalang MD, Medical Director, Sleep Medicine-East, Ohio State University Identifier: NCT01136122     History of Changes
Other Study ID Numbers: 2009H0304
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases