Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05896579

Conditions

COPD

Pulmonary Hypertension

Right Ventricular Dysfunction

Exercise

Exercise Training

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

Brief summary:

This study plans to learn 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 during rest and moderate- vs high-intensity 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

Exercise

Exercise Training

Study ID

NCT05896579

Start date

Aug 22, 2023

Status verified date

May, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 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 mild in severity; tricuspid regurgitation greater than moderate in severity)
  • 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
  • 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. severe osteoarthritis, imbalance/gait instability, etc.)
  • Pregnancy
  • Body mass index <18 or >40
  • Hematocrit <25% or >55%
  • For invasive CPET, chronic anticoagulation that is unable to be held for the study visit
  • For invasive CPET, forced expiratory volume in 1 second of <20%

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: COPD

Participants will complete testing at rest and during moderate- and high-intensity exercise to identify patterns of right ventricular responses.

Interventions

Exercise

After a brief warmup, participants will be asked to perform approximately 5 minutes of exercise at moderate intensity and then approximately 2 minutes of exercise at high intensity.

Primary outcome measure

  • Right ventricular contractility measured by transthoracic echocardiography [ Time Frame: Up to 1 hour ]

Central Contacts and Locations

Central contacts

Lindsay Forbes, MD

(303)724-4020lindsay.forbes@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Lindsay Forbes, MD

303-724-4020lindsay.forbes@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-08.