Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease (ReV UP COPD)

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Pulmonary Hypertension; Exercise Training; COPD; Right Ventricular Dysfunction
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsay Forbes, MD; Phone Number: (303)724-4020; Email: lindsay.forbes@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Lindsay Forbes, MD; Phone Number: 303-724-4020; Email: lindsay.forbes@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD; Participants will complete testing at rest and during moderate- and high-intensity exercise to identify patterns of right ventricular responses.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular contractility measured by transthoracic echocardiography	Global longitudinal strain, measured in absolute percent	Up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular contractility measured by conductance catheter	Maximum rate of pressure change, dP/dtmax in mmHg/sec	Up to 1 hour
Maximum oxygen consumption (VO2max)	In L/min	Up to 1 hour
Health-related quality of life by Short Form 36 (SF-36) questionnaire	Units, range 0-100 with greater scores indicating a more favorable health state	Up to 1 hour
Right ventricular systolic function measured by transthoracic echocardiography	Fractional area change on transthoracic echocardiography, measured in percent	Up to 1 hour
Right ventricular systolic function measured by transthoracic echocardiography	Tricuspid annular plane systolic excursion on transthoracic echocardiography, measured in centimeters	Up to 1 hour
Plasma acylcarnitines measured via ultra-high-performance liquid chromatography coupled to mass spectrometry	Peak intensity, measured as arbitrary units	Up to 1 hour
Physical activity measured by activity monitor	Time spent in moderate or vigorous activity in absolute percent	7 days

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Lindsay Forbes, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Ventricular Dysfunction; Hypertension; Pathological Conditions, Signs and Symptoms; Behavior; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Ventricular Dysfunction, Right; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 23-0516; K23HL175186 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No