NCT05896579 Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease
| NCT ID | NCT05896579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-08-22 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-08-22 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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%
Contact & Investigator
Lindsay Forbes, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT05896579 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05896579 currently recruiting?
Yes, NCT05896579 is actively recruiting participants. Contact the research team at lindsay.forbes@cuanschutz.edu for enrollment information.
Where is the NCT05896579 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05896579 clinical trial?
NCT05896579 is sponsored by University of Colorado, Denver. The principal investigator is Lindsay Forbes, MD at University of Colorado, Denver. The trial plans to enroll 60 participants.
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