Status:

RECRUITING

Right Ventricular Response to Exercise Among Patients With Chronic Obstructive Pulmonary Disease

Lead Sponsor:

University of Colorado, Denver

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

COPD

Pulmonary Hypertension

Eligibility:

All Genders

40+ years

Phase:

NA

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 r...

Eligibility Criteria

Inclusion Criteria:

  • COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] <0.7) • Age >= 40 years

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 supplemental oxygen 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)
  • World Health Organization Functional Class IV
  • Known pulmonary hypertension with mean pulmonary artery pressure >45 mmHg
  • Interstitial lung disease thought to be primary etiology of pulmonary hypertension
  • Untreated severe obstructive sleep apnea or obesity hypoventilation syndrome
  • Active malignancy (other than skin)
  • Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, imbalance/gait instability, etc.)
  • Pregnancy
  • Body mass index <18 or >35
  • Hematocrit <25% or >55%
  • For invasive CPET, chronic anticoagulation that is unable to be held for the study visit
  • For invasive CPET or Part 2 exercise training, forced expiratory volume in 1 second of <20%
  • For Part 2 exercise training, already engaged in routine exercise training (>30 minutes at >3 METs 3 times/week or more)
  • For Part 2 exercise training, unwillingness/inability to complete initial in-person exercise training sessions for approximately 35 minutes 3x/week for 3 weeks (followed by exercise training sessions with an option for hybrid remote/in-person participation)
  • For Part 2 exercise training with an option for hybrid remote exercise training, any medical conditions which threaten the safety of remote exercise training (e.g. imbalance/gait instability, etc.)

Key Trial Info

Start Date :

August 22 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2030

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05896579

Start Date

August 22 2023

End Date

August 1 2030

Last Update

April 14 2026

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045