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NCT Number: NCT05896579

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

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.

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Key information

Conditions

COPD Behavior Cardiovascular Diseases Chronic Disease Disease Attributes Exercise Exercise Training Heart Diseases Hypertension Hypertension, Pulmonary Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Hypertension Respiratory Tract Diseases Right Ventricular Dysfunction Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Right

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Lindsay Forbes, MD

CONTACT

[email protected]

303-724-4020

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

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.

Primary outcomes

  1. Right ventricular contractility measured by transthoracic echocardiography

    Time frame: Up to 1 hour

    Global longitudinal strain, measured in absolute percent

Secondary outcomes

  1. Right ventricular contractility measured by conductance catheter

    Time frame: Up to 1 hour

    Maximum rate of pressure change, dP/dtmax in mmHg/sec

  2. Right ventricular systolic function measured by transthoracic echocardiography

    Time frame: Up to 1 hour

    Fractional area change on transthoracic echocardiography, measured in percent

  3. Right ventricular systolic function measured by transthoracic echocardiography

    Time frame: Up to 1 hour

    Tricuspid annular plane systolic excursion on transthoracic echocardiography, measured in centimeters

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

    Time frame: Up to 1 hour

    Units, range 0-100 with greater scores indicating a more favorable health state

  5. Maximum oxygen consumption (VO2max)

    Time frame: Up to 1 hour

    In L/min

  6. Plasma acylcarnitines measured via ultra-high-performance liquid chromatography coupled to mass spectrometry

    Time frame: Up to 1 hour

    Peak intensity, measured as arbitrary units

  7. Physical activity measured by activity monitor

    Time frame: 7 days

    Time spent in moderate or vigorous activity in absolute percent

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay Forbes, MD

CONTACT

[email protected]

(303)724-4020

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jun 9, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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