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NCT05896579 | RECRUITING | COPD

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

University of Colorado, Denver

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.

Condition or disease

COPD

Pulmonary Hypertension

Right Ventricular Dysfunction

Intervention/treatment

Exercise training

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Identifying Patterns of Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Artery Enlargement
Actual Study Start Date : 2023-08-22
Estimated Primary Completion Date : 2030-07
Estimated Study Completion Date : 2030-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Identifying Right Ventricular Dysfunction in COPD Through Right Heart Catheterization, Imaging and Exercise

Location Details

NCT05896579

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045