Clinical trial NCT05896579: Identifying Right Ventricular Dysfunction in COPD Through Right Heart Catheterization, Imaging and Exercise
Official title: Identifying Patterns of Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Artery Enlargement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Pulmonary Hypertension
Right Ventricular Dysfunction
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study participants will undergo testing to identify patterns of right ventricular dysfunction. If a study participant decides to participate in exercise training, the participant will complete an exercise training intervention followed by repeat testing to determine impact of exercise training on right ventricular dysfunction.
Primary purpose: OTHER

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.


Eligibility 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 on most recent CT

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 \>10 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 ≤40%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mildin severity; tricuspid regurgitation greater than moderate in severity; diabetes with HbA1c \>8.5%)
* Volume overload (jugular vascular distension or greater than trace peripheral edema)
* Interstitial lung disease
* Untreated severe obstructive sleep apnea
* Active malignancy
* Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, etc.)
* Pregnancy
* Body mass index \<18 or \>35
* Hematocrit \<25% or \>55%
* 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, already engaged in routine exercise training (\>30 minutes at \>3 METs 3 times/week or more)

Primary outcomes:
measure: Right ventricular-arterial coupling measured by conductance catheter
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Mean pulmonary artery pressure measured by pulmonary artery catheter
timeFrame: Up to 1 hour
measure: Cardiac output measured by pulmonary artery catheter
timeFrame: Up to 1 hour
measure: Right ventricular contractility measured by conductance catheter
timeFrame: Up to 1 hour
measure: Right ventricular lusitropy measured by conductance catheter
timeFrame: Up to 1 hour
measure: Right ventricular energetics, measured by conductance catheter
timeFrame: Up to 1 hour
measure: Maximum oxygen consumption (VO2max)
timeFrame: Up to 1 hour
measure: Red blood cell acylcarnitine 10:0 measured by peripheral venous metabolomics(ultra-high performance liquid chromatography coupled to mass spectrometry)
timeFrame: Up to 1 hour
measure: Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics (ultra-high performance liquid chromatography coupled to mass spectrometry)
timeFrame: Up to 1 hour
measure: Health-related quality of life by Short Form 36 (SF-36) questionnaire
timeFrame: Up to 1 hour
measure: Right to left ventricle diameter ratio measured by computed tomography
timeFrame: Up to 1 hour
measure: Distal pulmonary vascular pruning measured by computed tomography
timeFrame: Up to 1 hour
measure: Right ventricular contractility measured by transthoracic echocardiography
timeFrame: Up to 1 hour
measure: Exercise training feasibility
timeFrame: 4 months
measure: Exercise training safety
timeFrame: 4 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Lindsay Forbes, MD
role: PRINCIPAL_INVESTIGATOR
References: