Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA
Keywords
Abstract
Description
Despite the high prevalence of overlap syndrome, few data are available on its pathophysiology and clinical consequences of these patients. Overlap syndrome has recently been reported to have excess cardiovascular mortality compared with COPD alone. However, no study has evaluated the mechanisms of excess cardiovascular mortality in untreated overlap syndrome. In addition, no prospective, randomized, controlled data are currently available on treatment of overlap syndrome.
This study is divided into two parts. The first part (Part 1) is a cross-sectional cohort study comparing subjects with overlap syndrome to those with COPD alone and those with OSA alone. Patients with COPD and OSA overlap syndrome will be evaluated by an overnight sleep study, cardiac MRI, serum inflammatory biomarker, urine catecholamine level, pulmonary function test, and questionnaires of sleep and health related quality of life. These measurement will be compared between overlap syndrome and control groups with either COPD or OSA alone.
The second part (Part 2) of the study is a prospective, parallel-group, randomized, controlled pilot study examining the effect of BPAP (and nocturnal oxygen if needed) vs. nocturnal oxygen therapy alone in patients with overlap syndrome (20 subjects in each treatment arm). The same measurement done during Part 1 will be repeated to evaluate the treatment effects.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 09/14/2014 |
| Estimated Enrollment Submitted: | 09/15/2014 |
| First Posted: | 09/18/2014 |
| Last Update Submitted: | 07/12/2020 |
| Last Update Posted: | 07/27/2020 |
| Date of first submitted results: | 05/13/2020 |
| Date of first submitted QC results: | 07/12/2020 |
| Date of first posted results: | 07/27/2020 |
| Actual Study Start Date: | 08/31/2014 |
| Estimated Primary Completion Date: | 01/31/2017 |
| Estimated Study Completion Date: | 01/31/2020 |
Condition or disease
Intervention/treatment
Device: Bi-level positive airway pressure (BPAP)
Drug: Nocturnal oxygen
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP) | Device: Bi-level positive airway pressure (BPAP) Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations <88% while on stable bi-level settings. |
| Active Comparator: Nocturnal oxygen Nocturnal oxygen | Drug: Nocturnal 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Both men and women with age more than 18 years. - Known diagnosis of stable COPD (GOLD stage 2 or higher) or OSA. Exclusion Criteria: - Already using continuous positive airway pressure (CPAP), BPAP device, or nocturnal oxygen. - Known or suspected renal failure with estimated Glomerular filtration (GFR) <50 ml/min/1.73 m2 or serum creatinine > 1.5 mg/dl. - Chronic atrial fibrillation or frequent premature ventricular contraction (> 10 beats per hour) - Women known to be pregnant or planning to be pregnant in next 6 months. - Known contraindication to MRI: cardiac pacemaker, metallic heart valves, metallic implants, history of claustrophobia. - If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit. - Uncontrolled COPD or acute COPD exacerbation. - Unstable cardiac diseases. - Known chronic inflammatory diseases like lupus or active infection. |
Outcome
Primary Outcome Measures
1. Right Ventricular Remodeling Index [Six months]
Secondary Outcome Measures
1. Right Ventricular Mass Index [Six months]
2. Right Ventricular End Systolic and Diastolic Volume [Six months]
3. Right Ventricular Ejection Fraction [Six months]
4. Myocardial Extracellular Volume [Six months]
5. Left Ventricular Remodeling Index [Six months]
6. Left Ventricular Mass Index [Six months]
7. Left Ventricular End Systolic and Diastolic Volume [6 months]
8. Left Ventricular Ejection Fraction [6 months]
9. Serum C-reactive Protein Level [6 months]
10. Serum Tumor Necrosis Factor-alpha Level [6 months]
11. Serum Interleukin-6 Level [6 months]
12. Serum Intercellular Adhesion Molecule-1 [6 months]
13. Serum P-selectin Level [6 months]
14. Urine Catecholamine Level [6 months]
15. 6 Minute Walk Distance [6 months]
16. Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ) [6 months]
17. Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS) [6 months]
18. Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI) [6 months]
19. General Health Status Through Short Form 36 (SF-36) Health Survey [6 months]
