Cardiac Hemodynamics in Overlap Syndrome (COPD With Obstructive Sleep Apnea)
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Purpose
Presence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S. population. Despite the high prevalence of overlap syndrome, little research has been done in this field. Overlap syndrome has been recently reported to have higher death rate than COPD alone, which is due to effect on the heart. However, the mechanisms by which overlap syndrome affects the heart are not known well. Also, the ideal treatment for overlap syndrome is not known.
This study is being done to find the mechanisms by which overlap syndrome affects the right and left sides of heart (using cardiac MRI to study the heart). We will also compare the effect of treatment with bi-level positive airway pressure device (BPAP) vs. night-time oxygen on heart in overlap syndrome. These aims will allow us to test the hypothesis that overlap syndrome patients have worse heart function than COPD only or OSA only, and treatment with BPAP device will improve the heart function better than oxygen only.
At the baseline visit, the subject will undergo an overnight sleep study in the hospital. In the morning, blood draw to measure serum inflammatory biomarkers (C-Reactive Protein, interleukin-6, P-selectin, ICAM-1, TNF-alpha), urine catecholamine level, six-minute walk test, questionnaire for health-related quality of life score and modified Medical Research Council (MMRC) dyspnea score, lung function tests, ultrasound of forearm blood vessels and cardiac MRI will be done. No follow-up visit is needed if the subject does not have sleep apnea. If the subject has sleep apnea based on the sleep study, he/she will be allotted to treatment with a BPAP device or night-time oxygen for 6 months. If the subject does not want to be treated with BPAP or oxygen, CPAP device will be used to treat sleep apnea. During the duration of study treatment, phone calls and a brief study visit at 3 months will be done to make sure there is no discomfort related to the treatment. After 6 months of study treatment, cardiac MRI, ultrasound of forearm blood vessels, lung function tests, blood draw for serum inflammatory biomarkers, urine catecholamine level, six-minute walk test, and questionnaires for dyspnea score and quality of life score will be repeated.
This study will help us in better understanding of mechanisms of high death rate due to effects on the heart in overlap syndrome. It will also help us in understanding better ways to treat sleep apnea in COPD patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Airway Disease (COPD) With Co-existent Obstructive Sleep Apnea (Overlap Syndrome) |
Device: Bi-level positive airway pressure (BPAP) Drug: Oxygen Device: CPAP |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Effects of Bi-level Positive Airway Pressure Therapy and Nocturnal Oxygen Therapy on Right and Left Ventricular Hemodynamics in Overlap Syndrome (Co-existent Chronic Obstructive Airway Disease and Obstructive Sleep Apnea) |
- Right ventricular end-diastolic volume [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Other cardiac hemodynamics parameters (end-systolic volume, ejection fraction, mass index and wall motion of right and left ventricles, coronary blood flow, pulmonary artery pressure and blood flow, etc.) [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Serum inflammatory biomarkers (C-reactive protein, interleukin-6, ICAM-1 and P-selectin) [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Urine catecholamine level [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Flow mediated dilatation of brachial artery [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Pulmonary Function tests [ Time Frame: Six months ] [ Designated as safety issue: No ]
- BODE Index [ Time Frame: Six months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 175 |
| Study Start Date: | November 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Bi-level positive airway pressure (BPAP) |
Device: Bi-level positive airway pressure (BPAP)
The level of BPAP will be titrated to treat OSA as well as hypoxemia and hypercapnia. The duration of therapy will be six months.
|
| Active Comparator: Nocturnal oxygen |
Drug: Oxygen
Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.
|
|
Active Comparator: Continuous positive airway pressure
The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months.
|
Device: CPAP
The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Both men and women with age more than 18 years.
- Known diagnosis of COPD (GOLD stage 2 or higher).
Exclusion Criteria:
- Already using CPAP or BPAP device.
- Estimated GFR <30 ml/min/1.73 m2 or on hemodialysis.
- Women known to be pregnant or planning to be pregnant in next 6 months.
- Cardiac pacemaker, metallic heart valves, metallic implants, claustrophobic.
- Chronic atrial fibrillation or frequent premature ventricular contractions.
- Using lipid-lowering medications, aspirin, oral steroids, steroid-sparing medications or anti-oxidant vitamin supplements.
- If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit.
- Contraindications to stress cardiac testing: acute myocardial infarction within 48 hours, unstable angina not yet stabilized with medical therapy, ongoing chest pain, active broncho-constriction, uncontrolled cardiac arrhythmia, symptomatic severe aortic stenosis, aortic dissection, acute pulmonary embolism or pericarditis.
- Uncontrolled COPD or acute COPD exacerbation.
- Known chronic inflammatory diseases like lupus or active infection.
Contacts and Locations| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Massachussets General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Atul Malhotra, MD | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | Atul Malhotra, MD, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01261377 History of Changes |
| Other Study ID Numbers: | 2010-P001753 |
| Study First Received: | December 15, 2010 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
Chronic obstructive airway disease, COPD, obstructive sleep apnea, OSA, BPAP, CPAP, positive airway pressure therapy, overlap syndrome |
Additional relevant MeSH terms:
|
Apnea Pulmonary Disease, Chronic Obstructive Sleep Apnea Syndromes Sleep Apnea, Obstructive Lung Diseases, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Lung Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013