Understanding heart function in COPD patients through exercise and imaging

Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease

This study is testing how exercise affects heart function in people with COPD to see if it can help us understand their heart health better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University of Colorado, Denver (other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT05896579 on ClinicalTrials.gov

What this trial studies

This study aims to investigate heart function in individuals with chronic obstructive pulmonary disease (COPD), focusing on how the right ventricle responds to pulmonary hypertension during both rest and exercise. By utilizing right heart catheterization and imaging techniques, the researchers will identify patterns of right ventricular dysfunction. The findings could lead to improved treatment strategies for COPD patients by enhancing our understanding of their cardiovascular health.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with COPD and evidence of pulmonary artery enlargement.

Not a fit: Patients with severe cardiovascular disease or those requiring high levels of supplemental oxygen may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better treatment options for patients with COPD and associated right ventricular dysfunction.

How similar studies have performed: While there is ongoing research in this area, this specific approach to understanding right ventricular dysfunction in COPD through exercise and imaging is relatively novel.

Eligibility criteria

Inclusion Criteria:

* COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \[FEV1/FVC\] \<0.7)
* Age \>= 40 years

Exclusion Criteria:

* Exacerbation of COPD 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 supplemental oxygen 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 mild in severity; tricuspid regurgitation greater than moderate in severity)
* Volume overload (jugular vascular distension or greater than trace peripheral edema)
* World Health Organization Functional Class IV
* Known pulmonary hypertension with mean pulmonary artery pressure \>45 mmHg
* Untreated severe obstructive sleep apnea or obesity hypoventilation syndrome
* Active malignancy (other than skin)
* Medical conditions that limit exercise on an upright stationary bicycle (e.g. severe osteoarthritis, imbalance/gait instability, etc.)
* Pregnancy
* Body mass index \<18 or \>40
* Hematocrit \<25% or \>55%
* For invasive CPET, chronic anticoagulation that is unable to be held for the study visit
* For invasive CPET, forced expiratory volume in 1 second of \<20%

Where this trial is running

Aurora, Colorado

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)

Study contacts

• Principal investigator: Lindsay Forbes, MD — University of Colorado, Denver
• Study coordinator: Lindsay Forbes, MD

Conditions: COPD, Pulmonary Hypertension, Right Ventricular Dysfunction, Exercise, Exercise Training