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CompletedNCT02244957Updated Jul 28, 2020Results posted

Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA

An interventional study of Bi-level positive airway pressure (BPAP) and Nocturnal oxygen in Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease and Overlap Syndrome, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea
  • Chronic Obstructive Pulmonary Disease
  • Overlap Syndrome
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 23 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    Bi-level positive airway pressure (BPAP)

    Bi-level positive airway pressure (BPAP)

    Device: Bi-level positive airway pressure (BPAP)

  • Active comparator
    Nocturnal oxygen

    Nocturnal oxygen

    Drug: Nocturnal oxygen

Interventions

  • DeviceBi-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.

    Also known as: BPAP

  • DrugNocturnal 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.

    Also known as: NOT

06

What researchers measure

Primary outcomes

  1. Right Ventricular Remodeling Index

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

    Time frame: Six months

Secondary outcomes

  1. Right Ventricular Mass Index

    MRI

    Time frame: Six months

  2. Right Ventricular End Systolic and Diastolic Volume

    MRI

    Time frame: Six months

  3. Right Ventricular Ejection Fraction

    MRI

    Time frame: Six months

  4. Myocardial Extracellular Volume

    MRI

    Time frame: Six months

  5. Left Ventricular Remodeling Index

    MRI

    Time frame: Six months

  6. Left Ventricular Mass Index

    MRI

    Time frame: Six months

  7. Left Ventricular End Systolic and Diastolic Volume

    MRI

    Time frame: 6 months

  8. Left Ventricular Ejection Fraction

    MRI

    Time frame: 6 months

  9. Serum C-reactive Protein Level

    blood test

    Time frame: 6 months

  10. Serum Tumor Necrosis Factor-alpha Level

    blood test

    Time frame: 6 months

  11. Serum Interleukin-6 Level

    blood test

    Time frame: 6 months

  12. Serum Intercellular Adhesion Molecule-1

    blood test

    Time frame: 6 months

  13. Serum P-selectin Level

    Blood test

    Time frame: 6 months

  14. Urine Catecholamine Level

    Urine test

    Time frame: 6 months

  15. 6 Minute Walk Distance

    Low-grade physical activity test

    Time frame: 6 months

  16. Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)

    Questionnaire

    Time frame: 6 months

  17. Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)

    Questionnaire

    Time frame: 6 months

  18. Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)

    Questionnaire

    Time frame: 6 months

  19. General Health Status Through Short Form 36 (SF-36) Health Survey

    Questionnaire

    Time frame: 6 months

07

Results

Posted Jul 28, 2020

Participant flow

Participant flow — Overall Study
MilestoneChronic Obstructive Pulmonary Disease (COPD)Overlap Syndrome
Started716
Completed616
Not completed10
Withdrew: Lack of efficacy10

Outcome measures

PrimaryRight Ventricular Remodeling Index

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

Time frame:
Six months
Reported as:
Mean · ratio
Right Ventricular Remodeling Index
ratioChronic Obstructive Pulmonary Disease (COPD)Overlap Syndrome
Right Ventricular Remodeling Index0.3747 ± 0.063350.2817 ± 0.03630
SecondaryRight Ventricular Mass Index

MRI

Time frame:
Six months

No measurements were reported for this outcome.

SecondaryRight Ventricular End Systolic and Diastolic Volume

MRI

Time frame:
Six months

No measurements were reported for this outcome.

SecondaryRight Ventricular Ejection Fraction

MRI

Time frame:
Six months

No measurements were reported for this outcome.

SecondaryMyocardial Extracellular Volume

MRI

Time frame:
Six months

No measurements were reported for this outcome.

SecondaryLeft Ventricular Remodeling Index

MRI

Time frame:
Six months

No measurements were reported for this outcome.

SecondaryLeft Ventricular Mass Index

MRI

Time frame:
Six months

No measurements were reported for this outcome.

SecondaryLeft Ventricular End Systolic and Diastolic Volume

MRI

Time frame:
6 months

No measurements were reported for this outcome.

SecondaryLeft Ventricular Ejection Fraction

MRI

Time frame:
6 months

No measurements were reported for this outcome.

SecondarySerum C-reactive Protein Level

blood test

Time frame:
6 months

No measurements were reported for this outcome.

SecondarySerum Tumor Necrosis Factor-alpha Level

blood test

Time frame:
6 months

No measurements were reported for this outcome.

SecondarySerum Interleukin-6 Level

blood test

Time frame:
6 months

No measurements were reported for this outcome.

SecondarySerum Intercellular Adhesion Molecule-1

blood test

Time frame:
6 months

No measurements were reported for this outcome.

SecondarySerum P-selectin Level

Blood test

Time frame:
6 months

No measurements were reported for this outcome.

SecondaryUrine Catecholamine Level

Urine test

Time frame:
6 months

No measurements were reported for this outcome.

Secondary6 Minute Walk Distance

Low-grade physical activity test

Time frame:
6 months

No measurements were reported for this outcome.

SecondaryQuality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)

Questionnaire

Time frame:
6 months

No measurements were reported for this outcome.

SecondaryDegree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)

Questionnaire

Time frame:
6 months

No measurements were reported for this outcome.

SecondarySleep Quality Through Pittsburgh Sleep Quality Index (PSQI)

Questionnaire

Time frame:
6 months

No measurements were reported for this outcome.

SecondaryGeneral Health Status Through Short Form 36 (SF-36) Health Survey

Questionnaire

Time frame:
6 months

No measurements were reported for this outcome.

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chronic Obstructive Pulmonary Disease (COPD)0/7 (0%)0/7 (0%)0/7 (0%)
Overlap Syndrome0/16 (0%)0/16 (0%)0/16 (0%)

Baseline characteristics

one subject was dropped due to lack of efficacy

Age, Continuous
Age, Continuous(years)Chronic Obstructive Pulmonary Disease (COPD)Overlap SyndromeTotal
Mean64 ± 6.463.5 ± 4.263.9 ± 5.8
Sex: Female, Male
Sex: Female, Male(Participants)Chronic Obstructive Pulmonary Disease (COPD)Overlap SyndromeTotal
Female527
Male11415
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Chronic Obstructive Pulmonary Disease (COPD)Overlap SyndromeTotal
Hispanic or Latino134
Not Hispanic or Latino51318
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Chronic Obstructive Pulmonary Disease (COPD)Overlap SyndromeTotal
United States61622
08

Study locations

1 site
  • University of California, San Diego
    San Diego, California 92093, United States
09

References and documents

Study documents

  • Study protocol · Mar 25, 2014

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02244957
Lead sponsor
University of California, San Diego
Responsible party
Robert L. Owens (Assistant Professor, University of California, San Diego) — Principal investigator
First posted
Sep 19, 2014
Start date
Sep 2014
Primary completion
Feb 2017
Completion
Feb 2020
Results posted
Jul 28, 2020
Last update
Jul 28, 2020

Study contacts

Robert L Owens, MD
principal investigator · UCSD

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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