Right Ventricular Response to Exercise Among Patients With Chronic Obstructive Pulmonary Disease
Recruiting · NCT07576894 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
Exercise training
What this trial is about
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 during rest and moderate- vs high-intensity exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Colorado Anschutz Medical Campus - Aurora, Colorado, United States