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

Last updated: August 5, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Heart Disease

High Blood Pressure (Hypertension)

Treatment

Exercise training

Clinical Study ID

NCT05896579
23-0516
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Exacerbation of COPD or use of systemic corticosteroids in the 3 months prior toenrollment

  • 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; leftventricular ejection fraction ≤40%; arrhythmia; pulmonic, mitral or aortic valvularabnormality greater than mildin severity; tricuspid regurgitation greater thanmoderate 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 fromUniversity of Colorado Anschutz Medical Campus or unwillingness/inability to attendexercise 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 routineexercise training (>30 minutes at >3 METs 3 times/week or more)

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Exercise training
Phase:
Study Start date:
August 22, 2023
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

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