COPDNCT05896579
Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease
A study testing Exercise 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 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, Right Ventricular Dysfunction
- What is being tested?
- Exercise
- 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
- 22 Aug 2023to 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%; 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 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%
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
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.
- Being tested
- Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Ventricular Dysfunction, Right, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| 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. Receives: Behavioral: Exercise |
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
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
Plasma acylcarnitines measured via ultra-high-performance liquid chromatography coupled to mass spectrometry
Peak intensity, measured as arbitrary units
Measured: Up to 1 hour
Physical activity measured by activity monitor
Time spent in moderate or vigorous activity in absolute percent
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start22 Aug 2023
- Primary completionMay 2030 (estimated)
- Study completionAug 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study participants will undergo testing to identify patterns of right ventricular response to moderate- vs high-intensity exercise.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsay Forbes, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896579
- Sponsor's protocol ID
- 23-0516
- Status last verified
- May 2026
- First submitted
- 31 May 2023
- 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
- NCT05896579
- Acronym / sponsor ID
- 23-0516
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 9 Jun 2023 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study participants will undergo testing to identify patterns of right ventricular response to moderate- vs high-intensity exercise.
| Arm | Type | Receives |
|---|---|---|
| COPD | Experimental | Behavioral: ExerciseParticipants will complete testing at rest and during moderate- and high-intensity exercise to identify patterns of right ventricular responses. |
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 (16 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%; 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 |
|---|---|---|
| ExerciseAfter 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. | 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
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
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 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 16 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; AzTrials last refreshed its copy on 31 Oct 2026.