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

NCT05896579 | Recruiting DMC

• 1 other identifier: 23-0516
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Right ventricular contractility measured by transthoracic echocardiography

  Global longitudinal strain, measured in absolute percent

  Up to 1 hour

Secondary Outcomes (7)

• Right ventricular contractility measured by conductance catheter

  Up to 1 hour

• Right ventricular systolic function measured by transthoracic echocardiography

  Up to 1 hour

• Right ventricular systolic function measured by transthoracic echocardiography

  Up to 1 hour

• Health-related quality of life by Short Form 36 (SF-36) questionnaire

  Up to 1 hour

• Maximum oxygen consumption (VO2max)

  Up to 1 hour

Study Arms (1)

COPD

EXPERIMENTAL

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

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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.

COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Ventricular Dysfunction, Right; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lindsay Forbes, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Forbes, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: August 22, 2023
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)