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Exercise Training for Right Ventricular Dysfunction in COPD
N/A
Recruiting
Led By Lindsay Forbes, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess how COPD affects heart function and explore new treatments to improve outcomes.
Who is the study for?
This trial is for adults with COPD, confirmed by specific lung function tests and signs of pulmonary artery enlargement. Participants should not have had a recent COPD flare-up or changes in treatment, must be able to exercise on a bike, and not already doing regular intense workouts. They can't join if they have severe heart issues, untreated sleep apnea, extreme body weight, certain blood conditions or are pregnant.
What is being tested?
The study focuses on how the right side of the heart functions in people with COPD when facing high lung pressure at rest and during exercise. It aims to uncover patterns of dysfunction that could lead to improved treatments for these patients.
What are the potential side effects?
Since this trial involves exercise training as an intervention rather than medication or surgery, typical side effects might include muscle soreness, fatigue or shortness of breath during physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Right ventricular-arterial coupling measured by conductance catheter
Secondary study objectives
Cardiac output measured by pulmonary artery catheter
Distal pulmonary vascular pruning measured by computed tomography
Exercise training feasibility
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: COPD with pulmonary artery enlargementExperimental Treatment1 Intervention
Participants will complete testing at rest and during exercise to identify patterns of right ventricular dysfunction. If a participant decides to participate in the optional exercise training program, the participant will complete exercise training followed by repeat testing to determine the impact of exercise training on right ventricular dysfunction.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise training
2019
Completed Phase 1
~1110
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,803 Previous Clinical Trials
2,822,087 Total Patients Enrolled
Lindsay Forbes, MDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have sleep apnea that has not been treated.I haven't had a severe COPD flare-up or used steroids in the last 3 months.I have a condition that prevents me from exercising on a bike.My COPD treatment has not changed in the last 3 weeks.My heart scans show pulmonary artery enlargement not during a COPD flare-up.I need more than 6 liters per minute of oxygen to breathe at rest.I have interstitial lung disease.I currently have cancer.I need more than 10 liters per minute of oxygen when I move around.I have swelling in my neck veins or slight swelling in my limbs.I do not have uncontrolled heart problems or severe diabetes.I live over 90 miles away from the University of Colorado Anschutz Medical Campus or cannot attend thrice-weekly exercise sessions.
Research Study Groups:
This trial has the following groups:- Group 1: COPD with pulmonary artery enlargement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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