COPDReV UP COPDNCT07576894
Right Ventricular Response to Exercise Among Patients With Chronic Obstructive Pulmonary Disease
A study testing Exercise training in people with COPD and Pulmonary Hypertension, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Pulmonary Hypertension, Exercise
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 1 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] <0.7)
- Age >= 40 years
Who cannot join
- 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%; uncontrolled 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)
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- World Health Organization Functional Class IV
- Known pulmonary hypertension with mean pulmonary artery pressure >45 mmHg
- Untreated severe obstructive sleep apnea and/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 >35
- Hematocrit <25% or >55%
- For subset undergoing right heart catheterization, chronic anticoagulation that is unable to be held for the study visit
- For subset undergoing right heart catheterization or exercise training, forced expiratory volume in 1 second of <20%
- For exercise training, already engaged in routine exercise training (>30 minutes at >3 METs 3 times/week or more)
- For exercise training, inability to complete initial in-person exercise training sessions for approximately 35 minutes 3x/week for 3 weeks (followed by exercise training sessions with an option for hybrid remote/in-person participation)
- For exercise training with an option for hybrid remote exercise training, any medical conditions which threaten the safety of remote exercise training (e.g. imbalance/gait instability, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Lindsay Forbes, MD, 303-724-4020, lindsay.forbes@cuanschutz.edu
About this study
Official title: Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease
This study plans to learn more 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.
Read the detailed description
This study will determine patterns of right ventricular (RV) response to aerobic exercise in patients with chronic obstructive pulmonary disease (COPD) and will design a targeted exercise intervention to improve RV response. We will study 60 patients with COPD. Participants will complete cardiopulmonary exercise testing (CPET) and transthoracic echocardiography (TTE) during rest, moderate- and high-intensity exercise. A subset of participants (n=16) who have been recommended to undergo clinical right heart catheterization will be recruited for the primary study with additional invasive pressure-volume analysis during the CPET. This testing will be used to validate measures of RV function obtained through noninvasive testing. The sample size was selected based upon our preliminary data and statistical analysis plans.
To test whether an exercise intervention targeted to RV response to exercise is feasible for patients, 12 participants will complete a targeted exercise training intervention based on their RV contractile response during baseline testing. This intervention will include participants who demonstrate RV contractility increase to moderate- but not high-intensity exercise. We will test the feasibility of a moderate-intensity interval training program. Participants will complete exercise training sessions 3x/week for 12 weeks. Exercise training will be performed on an upright stationary bicycle. Following the exercise training intervention, participants will repeat CPET and TTE. They will also complete a health-related quality of life questionnaire before and after the exercise training intervention.
- Conditions
- COPD, Pulmonary Hypertension, Exercise, Right Ventricular (RV) Dysfunction, Exercise Training
- Being tested
- Exercise training
- Keywords
- COPD, Pulmonary hypertension, Exercise, Pulmonary rehabilitation, Exercise training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Exercise training will include moderate-intensity interval training 3x/week.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Experimental | Participants will complete testing at rest and during moderate- and high-intensity exercise to identify patterns of right ventricular responses. Participants who based on baseline testing are eligible and decide to participate in the optional exercise training program will complete exercise training followed by repeat testing to determine the impact of exercise training on right ventricular dysfunction. Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular contractility measured by transthoracic echocardiography
Global longitudinal strain, measured in absolute percent
Measured: Up to 1 hour
Secondary outcomes (7)
Right ventricular contractility measured by conductance catheter
Maximum rate of pressure change, dP/dtmax in mmHg/sec
Measured: Up to 1 hour
Right ventricular systolic function measured by transthoracic echocardiography
Fractional area change on transthoracic echocardiography, measured in percent
Measured: Up to 1 hour
Right ventricular systolic function measured by transthoracic echocardiography
Tricuspid annular plane systolic excursion on transthoracic echocardiography, measured in centimeters
Measured: Up to 1 hour
Exercise training feasibility
Proportion of exercise training sessions completed
Measured: 4 months
Exercise training safety
Adverse events, reported or observed
Measured: 4 months
Health-related quality of life by Short Form 36 (SF-36) questionnaire
Units, range 0-100 with greater scores indicating a more favorable health state
Measured: Up to 1 hour
Maximum oxygen consumption (VO2max)
In L/min
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Aug 2025
- Primary completion1 May 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Lindsay Forbes, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576894
- Sponsor's protocol ID
- 23-0516b
- Other IDs
- K23HL175186
- Acronym
- ReV UP COPD
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07576894
- Acronym / sponsor ID
- ReV UP COPD / 23-0516b
- Conditions
- COPD, Pulmonary Hypertension, Exercise, Right Ventricular (RV) Dysfunction, Exercise Training
- Keywords
- COPD, Pulmonary hypertension, Exercise, Pulmonary rehabilitation, Exercise training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to learn more 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.
Detailed description
This study will determine patterns of right ventricular (RV) response to aerobic exercise in patients with chronic obstructive pulmonary disease (COPD) and will design a targeted exercise intervention to improve RV response. We will study 60 patients with COPD. Participants will complete cardiopulmonary exercise testing (CPET) and transthoracic echocardiography (TTE) during rest, moderate- and high-intensity exercise. A subset of participants (n=16) who have been recommended to undergo clinical right heart catheterization will be recruited for the primary study with additional invasive pressure-volume analysis during the CPET. This testing will be used to validate measures of RV function obtained through noninvasive testing. The sample size was selected based upon our preliminary data and statistical analysis plans.
To test whether an exercise intervention targeted to RV response to exercise is feasible for patients, 12 participants will complete a targeted exercise training intervention based on their RV contractile response during baseline testing. This intervention will include participants who demonstrate RV contractility increase to moderate- but not high-intensity exercise. We will test the feasibility of a moderate-intensity interval training program. Participants will complete exercise training sessions 3x/week for 12 weeks. Exercise training will be performed on an upright stationary bicycle. Following the exercise training intervention, participants will repeat CPET and TTE. They will also complete a health-related quality of life questionnaire before and after the exercise training intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | Experimental | Behavioral: Exercise trainingParticipants will complete testing at rest and during moderate- and high-intensity exercise to identify patterns of right ventricular responses. Participants who based on baseline testing are eligible and decide to participate in the optional exercise training program will complete exercise training followed by repeat testing to determine the impact of exercise training on right ventricular dysfunction. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] <0.7)
- Age >= 40 years
Key exclusion criteria (19 listed)
- 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%; uncontrolled arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mild in severity; tricuspid regurgitation greater than moderate in severity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingExercise training will include moderate-intensity interval training 3x/week. | Behavioural | COPD |
Primary outcome
Right ventricular contractility measured by transthoracic echocardiography
Time frame: Up to 1 hour
Global longitudinal strain, measured in absolute percent
7 secondary outcomes
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
Exercise training feasibility
Time frame: 4 months
Exercise training safety
Time frame: 4 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsay Forbes, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with COPD and Pulmonary Hypertension, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay Forbes, MD ((303)724-4020, lindsay.forbes@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular contractility measured by transthoracic echocardiography (time frame: Up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.