Right‑side heart response to exercise in people with COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.