Status:
RECRUITING
Right Ventricular Response to Exercise Among Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
COPD
Pulmonary Hypertension
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 r...
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 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 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 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)
- World Health Organization Functional Class IV
- Known pulmonary hypertension with mean pulmonary artery pressure >45 mmHg
- Interstitial lung disease thought to be primary etiology of pulmonary hypertension
- 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. osteoarthritis, imbalance/gait instability, etc.)
- Pregnancy
- Body mass index <18 or >35
- Hematocrit <25% or >55%
- For invasive CPET, chronic anticoagulation that is unable to be held for the study visit
- For invasive CPET or Part 2 exercise training, forced expiratory volume in 1 second of <20%
- For Part 2 exercise training, already engaged in routine exercise training (>30 minutes at >3 METs 3 times/week or more)
- For Part 2 exercise training, unwillingness/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 Part 2 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.)
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05896579
Start Date
August 22 2023
End Date
August 1 2030
Last Update
April 14 2026
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045