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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the heart’s right pumping chamber works at rest and during moderate and hard exercise. It is for adults age 40 or older with COPD, a long-term lung disease that makes breathing hard.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 or older.
  • Have COPD confirmed by a breathing test showing an FEV1/FVC ratio below 0.7.

Who can't join

  • A COPD flare-up in the past 3 months, or a change in COPD treatment in the past 3 weeks.
  • Need more than 6 liters of oxygen per minute at rest, or more than 10 liters per minute during activity.
  • Active or uncontrolled heart or blood vessel disease, or too much fluid in the body, shown by swollen neck veins or more than slight swelling in the arms or legs.
  • WHO functional class IV, meaning symptoms even at rest, or known high blood pressure in the lungs with an average lung artery pressure above 45 mmHg.
  • Untreated severe sleep apnea (breathing that stops during sleep), obesity-related shallow breathing, or active cancer other than skin cancer.
  • A condition that limits riding an upright exercise bike, pregnancy, or a body mass index (BMI) below 18 or above 40.
  • A hematocrit below 25% or above 55%. This is the share of blood made up of red blood cells.
  • For exercise testing with tubes placed in blood vessels: taking long-term blood thinners that cannot be paused for the visit, or an FEV1 breathing test result below 20%.

Simplified for readability. The official criteria below are what the study team uses.

Official 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%

Study sites (1)

CO