Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA

NCT02244957 | Completed Results

• 1 other identifier: UCSD140959
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Overlap Syndrome

Outcome Measures

Primary Outcomes (1)

• Right Ventricular Remodeling Index

  Defined as the ratio between RVMI and RV end-diastolic volume index using MRI

  Six months

Secondary Outcomes (19)

• Right Ventricular Mass Index

  Six months

• Right Ventricular End Systolic and Diastolic Volume

  Six months

• Right Ventricular Ejection Fraction

  Six months

• Myocardial Extracellular Volume

  Six months

• Left Ventricular Remodeling Index

  Six months

Study Arms (2)

Bi-level positive airway pressure (BPAP)

ACTIVE COMPARATOR

Bi-level positive airway pressure (BPAP)

Device: Bi-level positive airway pressure (BPAP)

Nocturnal oxygen

ACTIVE COMPARATOR

Nocturnal oxygen

Drug: Nocturnal oxygen

Interventions

Bi-level positive airway pressure (BPAP) 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.

Also known as: BPAP

Bi-level positive airway pressure (BPAP)

Nocturnal oxygen 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.

Also known as: NOT

Nocturnal oxygen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both men and women with age more than 18 years.
• Known diagnosis of stable COPD (GOLD stage 2 or higher) or OSA.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dillon Gilbertson
• Organization: UCSD

dcgilbertson@health.ucsd.edu

8582452155

Study Officials

• Robert L Owens, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2020
• Last Updated: July 28, 2020
• Results First Posted: July 28, 2020

Record last verified: 2020-07

Locations

US (1)