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Recruiting NCT05896579

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

No phase Interventional COPD Pulmonary Hypertension Right Ventricular Dysfunction Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: COPD, Pulmonary Hypertension, Right Ventricular Dysfunction, Exercise. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • Right ventricular contractility measured by transthoracic echocardiography [Time frame: Up to 1 hour]
Secondary outcome measures (7)
  • Right ventricular contractility measured by conductance catheter [Time frame: Up to 1 hour]
  • Right ventricular systolic function measured by transthoracic echocardiography [Time frame: Up to 1 hour]
  • Right ventricular systolic function measured by transthoracic echocardiography [Time frame: Up to 1 hour]
  • Health-related quality of life by Short Form 36 (SF-36) questionnaire [Time frame: Up to 1 hour]
  • Maximum oxygen consumption (VO2max) [Time frame: Up to 1 hour]
  • Plasma acylcarnitines measured via ultra-high-performance liquid chromatography coupled to mass spectrometry [Time frame: Up to 1 hour]
  • Physical activity measured by activity monitor [Time frame: 7 days]

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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT05896579 · 23-0516

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗