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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 13, 2013
Last verified: December 2013
  Purpose

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 Intervention
Obstructive Sleep Apnea
Device: CPAP Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effects of Positive Airway Pressure (PAP) Treatment of Obstructive Sleep Apnea (OSA) in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad. [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: April 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136122

Contacts
Contact: Pulmonary Clinical Trials Office 614-293-4978 Lung.Research@osumc.edu

Locations
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Pulmonary Clinical Trials Office    614-293-4978    Lung.Research@osumc.edu   
Contact: Melissa Michetti    614-366-2761    Melissa.Michetti@osumc.edu   
Principal Investigator: Ulysses Magalang, M.D.         
Sponsors and Collaborators
Ulysses Magalang MD
Investigators
Principal Investigator: Ulysses Magalang, M.D. Ohio State University
  More Information

No publications provided

Responsible Party: Ulysses Magalang MD, Medical Director, Sleep Medicine-East, The Ohio State University
ClinicalTrials.gov Identifier: NCT01136122     History of Changes
Other Study ID Numbers: 2009H0304
Study First Received: May 17, 2010
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 18, 2014