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New treatment option for COPD
Official title Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT05896579
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] \<0.7)
- Age \>= 40 years
You likely can't join 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...
- Volume overload (jugular vascular distension or greater than trace peripheral edema)
See the full eligibility criteria
- COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] \<0.7)
- Age \>= 40 years
- 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...
- 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 \ 40
- Hematocrit \ 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%
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.