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Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease

Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05896579
Enrollment
60
Registered
2023-06-09
Start date
2023-08-22
Completion date
2030-08-01
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Exercise, Exercise Training, Pulmonary Hypertension, Right Ventricular Dysfunction

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.

Interventions

BEHAVIORALExercise

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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Study participants will undergo testing to identify patterns of right ventricular response to moderate- vs high-intensity exercise.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frameDescription
Right ventricular contractility measured by transthoracic echocardiographyUp to 1 hourGlobal longitudinal strain, measured in absolute percent

Secondary

MeasureTime frameDescription
Right ventricular contractility measured by conductance catheterUp to 1 hourMaximum rate of pressure change, dP/dtmax in mmHg/sec
Right ventricular systolic function measured by transthoracic echocardiographyUp to 1 hourFractional area change on transthoracic echocardiography, measured in percent
Health-related quality of life by Short Form 36 (SF-36) questionnaireUp to 1 hourUnits, range 0-100 with greater scores indicating a more favorable health state
Maximum oxygen consumption (VO2max)Up to 1 hourIn L/min
Plasma acylcarnitines measured via ultra-high-performance liquid chromatography coupled to mass spectrometryUp to 1 hourPeak intensity, measured as arbitrary units
Physical activity measured by activity monitor7 daysTime spent in moderate or vigorous activity in absolute percent

Countries

United States

Contacts

CONTACTLindsay Forbes, MD
lindsay.forbes@cuanschutz.edu(303)724-4020
PRINCIPAL_INVESTIGATORLindsay Forbes, MD

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026