Identifying Right Ventricular Dysfunction in COPD Through Right Heart Catheterization, Imaging and Exercise

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Right Ventricular Dysfunction; COPD; Pulmonary Hypertension

Treatments: Behavioral: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05896579

23-0516

Details and patient eligibility

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 to pulmonary hypertension (high pressure in the lungs) during rest and exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.

Enrollment: 36 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] <0.7) • Pulmonary artery enlargement determined by pulmonary artery-to-aorta ratio >1 or >30 mm on most recent CT

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 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)
• Interstitial lung disease
• Untreated severe obstructive sleep apnea
• Active malignancy
• Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, etc.)
• Pregnancy
• Body mass index <18 or >35
• Hematocrit <25% or >55%
• For optional Part 2 i.e. exercise training and Visit 2, residence >90 miles from University of Colorado Anschutz Medical Campus or unwillingness/inability to attend exercise training sessions for approximately 35 minutes 3x/week for 12 weeks
• For optional Part 2 i.e. exercise training and Visit 2, already engaged in routine exercise training (>30 minutes at >3 METs 3 times/week or more)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

COPD with pulmonary artery enlargement

Experimental group

Description:

Participants will complete testing at rest and during exercise to identify patterns of right ventricular dysfunction. If a participant decides to participate in the optional exercise training program, the participant will complete exercise training followed by repeat testing to determine the impact of exercise training on right ventricular dysfunction.

Treatment:

Behavioral: Exercise training