Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Right Ventricular Hemodynamics Using Cardiac Magnetic Resonance Imaging in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244957
• Other study ID #: UCSD140959
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: February 2020

Study information

• Verified date: July 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2020
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Sleep Apnea
• Overlap Syndrome
• Pulmonary Disease, Chronic Obstructive
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Undifferentiated Connective Tissue Diseases

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right Ventricular Remodeling Index	Defined as the ratio between RVMI and RV end-diastolic volume index using MRI	Six months
Secondary	Right Ventricular Mass Index	MRI	Six months
Secondary	Right Ventricular End Systolic and Diastolic Volume	MRI	Six months
Secondary	Right Ventricular Ejection Fraction	MRI	Six months
Secondary	Myocardial Extracellular Volume	MRI	Six months
Secondary	Left Ventricular Remodeling Index	MRI	Six months
Secondary	Left Ventricular Mass Index	MRI	Six months
Secondary	Left Ventricular End Systolic and Diastolic Volume	MRI	6 months
Secondary	Left Ventricular Ejection Fraction	MRI	6 months
Secondary	Serum C-reactive Protein Level	blood test	6 months
Secondary	Serum Tumor Necrosis Factor-alpha Level	blood test	6 months
Secondary	Serum Interleukin-6 Level	blood test	6 months
Secondary	Serum Intercellular Adhesion Molecule-1	blood test	6 months
Secondary	Serum P-selectin Level	Blood test	6 months
Secondary	Urine Catecholamine Level	Urine test	6 months
Secondary	6 Minute Walk Distance	Low-grade physical activity test	6 months
Secondary	Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)	Questionnaire	6 months
Secondary	Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)	Questionnaire	6 months
Secondary	Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)	Questionnaire	6 months
Secondary	General Health Status Through Short Form 36 (SF-36) Health Survey	Questionnaire	6 months