N/A
Completed N=23
Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA
Obstructive Sleep Apnea · Chronic Obstructive Pulmonary Disease · Overlap Syndrome
Source: ClinicalTrials.gov NCT02244957 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Right Ventricular Remodeling Index — 0.3747; 0.2817 ratio
Summary
The coexistence 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.The investigators propose to conduct this study that aims: (1) to compare right and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI) in overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level positive airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV) hemodynamics in overlap syndrome.
This study will allow us to test the hypothesis: (1) Patients with overlap syndrome have more RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia and hypercapnia during sleep will improve RV hemodynamics compared with treatment of hypoxemia alone in patients with overlap syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Right Ventricular Remodeling Index |
0.3747; 0.2817 | — |
| SECONDARY Right Ventricular Mass Index |
— | — |
| SECONDARY Right Ventricular End Systolic and Diastolic Volume |
— | — |
| SECONDARY Right Ventricular Ejection Fraction |
— | — |
| SECONDARY Myocardial Extracellular Volume |
— | — |
| SECONDARY Left Ventricular Remodeling Index |
— | — |
| SECONDARY Left Ventricular Mass Index |
— | — |
| SECONDARY Left Ventricular End Systolic and Diastolic Volume |
— | — |
| SECONDARY Left Ventricular Ejection Fraction |
— | — |
| SECONDARY Serum C-reactive Protein Level |
— | — |
| SECONDARY Serum Tumor Necrosis Factor-alpha Level |
— | — |
| SECONDARY Serum Interleukin-6 Level |
— | — |
| SECONDARY Serum Intercellular Adhesion Molecule-1 |
— | — |
| SECONDARY Serum P-selectin Level |
— | — |
| SECONDARY Urine Catecholamine Level |
— | — |
| SECONDARY 6 Minute Walk Distance |
— | — |
| SECONDARY Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ) |
— | — |
| SECONDARY Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS) |
— | — |
| SECONDARY Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI) |
— | — |
| SECONDARY General Health Status Through Short Form 36 (SF-36) Health Survey |
— | — |
Eligibility 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) 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.
Data sourced from ClinicalTrials.gov (NCT02244957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.