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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Ulysses Magalang MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01136122
First received: May 17, 2010
Last updated: September 23, 2014
Last verified: September 2014

May 17, 2010
September 23, 2014
April 2010
February 2015   (final data collection date for primary outcome measure)
Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad. [ Time Frame: One month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01136122 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of PAP Treatment of OSA in Patients With Heart Failure
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Obstructive Sleep Apnea
Device: CPAP Treatment
Effective CPAP treatment for one month
Other Name: CPAP
  • Active Comparator: CPAP Arm
    Receive effective CPAP treatment for one month
    Intervention: Device: CPAP Treatment
  • No Intervention: Control Arm
    Receive no treatment for one month
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Pulmonary Clinical Trials Office 614-293-4978 Lung.Research@osumc.edu
United States
 
NCT01136122
2009H0304
No
Ulysses Magalang MD, The Ohio State University
Ulysses Magalang MD
Not Provided
Principal Investigator: Ulysses Magalang, M.D. Ohio State University
Ohio State University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP