Identifying Right Ventricular Dysfunction in COPD Through Right Heart Catheterization, Imaging and Exercise

Launched by UNIVERSITY OF COLORADO, DENVER · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how the heart functions in people with chronic obstructive pulmonary disease (COPD), particularly focusing on the right side of the heart. Researchers want to learn how high blood pressure in the lungs, known as pulmonary hypertension, affects the right side of the heart when a person is resting and when they are exercising. By understanding these patterns, the study aims to find better treatment options for COPD patients in the future.

To participate in the trial, individuals must have COPD, which is diagnosed by specific lung function tests, and a certain level of enlargement in the pulmonary artery shown on a recent CT scan. However, people with recent exacerbations of COPD, significant heart issues, or those who require high levels of supplemental oxygen may not be eligible. Participants can expect to undergo tests that include heart catheterization, imaging, and exercise assessments. It's important to note that this trial is currently recruiting and is open to individuals of all genders aged between 18 and 80.

Gender

ALL

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)