Right‑side heart response to exercise in people with COPD
Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease
This project will test how the right side of the heart responds to moderate and high‑intensity exercise in adults 40 and older with COPD and whether a targeted moderate‑intensity cycling program can improve that response.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT07576894 on ClinicalTrials.gov |
What this trial studies
This interventional study will enroll 60 patients with COPD to map patterns of right ventricular (RV) function using cardiopulmonary exercise testing (CPET) and transthoracic echocardiography (TTE) at rest and during moderate‑ and high‑intensity exercise. A subset of up to 16 participants scheduled for clinical right heart catheterization will undergo invasive pressure–volume analysis during CPET to validate noninvasive RV measures. Based on baseline RV contractile responses, 12 participants who increase RV contractility at moderate but not high intensity will complete a 12‑week, supervised moderate‑intensity interval training program on an upright stationary bicycle (3 sessions/week). After training, participants will repeat CPET/TTE to determine feasibility and change in RV response measures.
Who should consider this trial
Good fit: Adults aged 40 or older with COPD confirmed by FEV1/FVC < 0.7 who are clinically stable (no recent exacerbation or medication changes) and who do not require high‑flow supplemental oxygen or have uncontrolled cardiac disease are the ideal candidates.
Not a fit: Patients with advanced pulmonary hypertension (mean pulmonary artery pressure >45 mmHg), WHO functional class IV, large resting or exertional oxygen requirements, volume overload, or uncontrolled cardiovascular disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could enable tailored exercise programs that improve right ventricular function and exercise tolerance in some people with COPD.
How similar studies have performed: Pulmonary rehabilitation and exercise training improve symptoms and capacity in COPD, but using exercise response patterns to target RV‑focused training and validating noninvasive RV measures against invasive pressure–volume analysis is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion 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%; uncontrolled 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 and/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 \>35 * Hematocrit \<25% or \>55% * For subset undergoing right heart catheterization, chronic anticoagulation that is unable to be held for the study visit * For subset undergoing right heart catheterization or exercise training, forced expiratory volume in 1 second of \<20% * For exercise training, already engaged in routine exercise training (\>30 minutes at \>3 METs 3 times/week or more) * For exercise training, inability to complete initial in-person exercise training sessions for approximately 35 minutes 3x/week for 3 weeks (followed by exercise training sessions with an option for hybrid remote/in-person participation) * For exercise training with an option for hybrid remote exercise training, any medical conditions which threaten the safety of remote exercise training (e.g. imbalance/gait instability, etc.).
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
- Email: lindsay.forbes@cuanschutz.edu
- Phone: (303)724-4020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.