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

NCT ID: NCT05896579

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-22
• Study Completion Date: 2030-07-31

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 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.

Conditions

COPD; Pulmonary Hypertension; Right Ventricular Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

COPD with pulmonary artery enlargement

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.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

Exercise training will include supervised high-intensity interval training for \~35 minutes 3x/week on an upright stationary bicycle and unsupervised continuous aerobic exercise for \~30 minutes 2x/week.

Interventions

Exercise training

Exercise training will include supervised high-intensity interval training for \~35 minutes 3x/week on an upright stationary bicycle and unsupervised continuous aerobic exercise for \~30 minutes 2x/week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay Forbes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsay Forbes, MD

Role: CONTACT

lindsay.forbes@cuanschutz.edu

(720)892-6017

William Cornwell, MD, MSCS

Role: CONTACT

william.cornwell@cuanschutz.edu

Facility Contacts

Lindsay "Shelley" Forbes, MD

Role: primary

lindsay.forbes@cuanschutz.edu

720-892-6017

Other Identifiers

23-0516

Identifier Type: -

Identifier Source: org_study_id