Actively Recruiting
Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease
Led by University of Colorado, Denver · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating heart function in people with chronic obstructive pulmonary disease (COPD), focusing on how the right side of the heart (right ventricle) responds to rest and different levels of exercise. This study aims to understand patterns of right ventricular dysfunction during moderate and high-intensity exercise to help improve future treatments for COPD patients. The study involves 60 COPD patients who will undergo various tests including cardiopulmonary exercise testing (CPET) and echocardiography at rest and during exercise. A smaller group of 16 participants will have additional invasive heart pressure measurements during exercise to confirm the noninvasive test results. Additionally, 12 participants showing a specific heart response will take part in a 12-week moderate-intensity exercise training program on a stationary bike, exercising three times per week. Before and after this training, participants will repeat the tests and complete quality of life questionnaires. Participants will be closely monitored with heart function tests during rest and exercise, and some will have invasive measurements for detailed heart analysis. Those in the exercise program will have their heart function and quality of life assessed before and after training. The study will measure right ventricular contractility and systolic function using echocardiography and catheter data, as well as overall exercise capacity and training safety. The total study participation spans several months, including the exercise training and follow-up assessments.
CONDITIONS
Brief Title
Right Ventricular Response to Exercise Among Patients With Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of COPD confirmed by FEV1/FVC ratio less than 0.7
- Age 40 years or older
You will not qualify if you...
- COPD worsening in the 3 months before enrollment
- Change in COPD treatment in the 3 weeks before enrollment
- Need for more than 6 liters per minute supplemental oxygen at rest
- Need for more than 10 liters per minute supplemental oxygen during exercise
- Active or uncontrolled heart disease such as severe hypertension (blood pressure over 150/100), angina, low left ventricular ejection fraction (40% or less), uncontrolled arrhythmia, or significant heart valve problems
- Signs of volume overload like jugular vein distension or more than trace swelling in legs
- World Health Organization Functional Class IV
- Known pulmonary hypertension with mean pulmonary artery pressure over 45 mmHg
- Untreated severe obstructive sleep apnea or obesity hypoventilation syndrome
- Active cancer except skin cancer
- Medical conditions preventing safe exercise on a stationary bike (e.g., severe osteoarthritis, balance problems)
- Pregnancy
- Body mass index less than 18 or greater than 35
- Hematocrit less than 25% or greater than 55%
- For participants undergoing right heart catheterization, inability to stop chronic anticoagulation
- For catheterization or exercise training, forced expiratory volume in 1 second less than 20%
- For exercise training, currently doing regular exercise training over 30 minutes at more than 3 METs three times a week or more
- For exercise training, inability to complete initial 35-minute exercise sessions three times a week for 3 weeks
- For hybrid remote exercise training, medical conditions that make remote exercise unsafe (e.g., balance problems)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants complete cardiopulmonary exercise testing and echocardiography at rest and during moderate- and high-intensity exercise to assess right ventricular response.
1 visit (in-person)
Duration - 12 weeks
Eligible participants complete a moderate-intensity interval training program on a stationary bicycle three times per week to improve right ventricular function.
3 visits per week for 12 weeks (in-person exercise sessions)
Duration - Up to 1 day
Participants repeat cardiopulmonary exercise testing, echocardiography, and complete a quality of life questionnaire to assess the impact of the exercise training.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
L
Lindsay Forbes, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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