Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA

NCT ID: NCT02244957

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2020-02-29

Brief 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.

Detailed 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.

Conditions

Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Overlap Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bi-level positive airway pressure (BPAP)

Bi-level positive airway pressure (BPAP)

Group Type: ACTIVE_COMPARATOR

Bi-level positive airway pressure (BPAP)

Intervention Type: DEVICE

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.

Nocturnal oxygen

Nocturnal oxygen

Group Type: ACTIVE_COMPARATOR

Nocturnal oxygen

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

BPAP; NOT

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) <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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Robert L. Owens

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert L Owens, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California, San Diego

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

UCSD140959

Identifier Type: -

Identifier Source: org_study_id