Identifying Right Ventricular Dysfunction in COPD Through Right Heart Catheterization, Imaging and Exercise
Study Details
Study Description
Brief Summary
This study plans to learn more about heart function among individuals with chronic obstructive pulmonary disease (COPD). In particular, the investigators want to understand the different patterns of right ventricular response to pulmonary hypertension (high pressure in the lungs) during rest and exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: COPD with pulmonary artery enlargement Participants will complete testing to identify patterns of right ventricular dysfunction. If a participant decides to participate in the optional exercise training program, the participant will complete exercise training followed by repeat testing to determine the impact of exercise training on right ventricular dysfunction. |
Behavioral: Exercise training
Exercise training will include supervised high-intensity interval training for ~35 minutes 3x/week on an upright stationary bicycle and unsupervised continuous aerobic exercise for ~30 minutes 2x/week.
|
Outcome Measures
Primary Outcome Measures
- Right ventricular-arterial coupling measured by conductance catheter [Up to 1 hour]
Ratio of end-systolic elastance to effective arterial elastance (Ees/EA)
Secondary Outcome Measures
- Mean pulmonary artery pressure measured by pulmonary artery catheter [Up to 1 hour]
In mmHg
- Cardiac output measured by pulmonary artery catheter [Up to 1 hour]
In L/min, calculated by Fick equation
- Right ventricular contractility measured by conductance catheter [Up to 1 hour]
Maximum rate of pressure change, dP/dtmax in mmHg/sec
- Right ventricular lusitropy measured by conductance catheter [Up to 1 hour]
Minimum rate of pressure change, dP/dtmin in mmHg/sec
- Right ventricular energetics, measured by conductance catheter [Up to 1 hour]
Stroke work in mmHg*mL
- Right ventricular ejection fraction by cardiac magnetic resonance imaging [Up to 1 hour]
In %
- Right ventricular non-invasive ventricular-vascular coupling ratio by cardiac magnetic resonance imaging [Up to 1 hour]
Ratio of stroke volume to end-systolic volume
- Maximum oxygen consumption (VO2max) [Up to 1 hour]
In L/min
- Red blood cell acylcarnitine 10:0 measured by peripheral venous metabolomics(ultra-high performance liquid chromatography coupled to mass spectrometry) [Up to 1 hour]
Relative ion count
- Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics(ultra-high performance liquid chromatography coupled to mass spectrometry) [Up to 1 hour]
Relative ion count
- Health-related quality of life by COPD Assessment Test (CAT) questionnaire [Up to 1 hour]
Units, range 0-40 with greater scores indicating greater impairment in quality of life
Eligibility Criteria
Criteria
Inclusion Criteria:
- COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] <0.7) • Pulmonary artery enlargement determined by pulmonary artery-to-aorta ratio >1 or >30 mm obtained within 3 years of enrollment and not during an acute exacerbation of COPD
Exclusion Criteria:
-
Exacerbation of COPD or use of systemic corticosteroids in the 3 months prior to enrollment
-
Change in COPD therapy in the 3 weeks prior to enrollment
-
Requirement of >6 LPM supplemental oxygen at rest
-
Requirement of >6 LPM with exertion
-
Active/uncontrolled cardiovascular disease (e.g. hypertension with blood pressure
150/100 despite antihypertensives; coronary artery disease with angina; left ventricular ejection fraction ≤45%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than trace in severity; tricuspid regurgitation greater than mild in severity; diabetes with HbA1c >7.5%)
-
Volume overload (jugular vascular distension or greater than trace peripheral edema)
-
Interstitial lung disease
-
Untreated obstructive sleep apnea
-
Active malignancy
-
Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, etc.)
-
Already engaged in routine exercise training (>30 minutes at >3 METs 3 times/week or more)
-
Pregnancy
-
Body mass index <18.5 or >35
-
Hematocrit <32% or >55%
-
Contraindication to CMR (e.g. metallic or electrical implants, devices, or foreign bodies; severe renal insufficiency with estimated glomerular filtration rate <30 mL/min/1.73 m2)
-
For optional Part 2 i.e. exercise training and Visit 2, residence >90 miles from University of Colorado Anschutz Medical Campus or unwillingness/inability to attend exercise training sessions for approximately 35 minutes 3x/week for 12 weeks
-
For optional Part 2 i.e. exercise training and Visit 2, unwillingness to comply with exercise gym COVID precautions, including being up-to-date on COVID vaccination (primary series plus one booster, if eligible)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Anschutz Medical Campus | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
Investigators
- Principal Investigator: Lindsay Forbes, MD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-0516