ClinicalTrials.gg
RecruitingNCT05896579Updated May 8, 2026

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

An interventional study of Exercise in COPD, Pulmonary Hypertension and Right Ventricular Dysfunction, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.

02

Conditions studied

  • COPD
  • Pulmonary Hypertension
  • Right Ventricular Dysfunction
  • Exercise
  • Exercise Training
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 60 is close to the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (determined by ratio of to forced vital capacity [FEV1/FVC] \<0.7)
  • Age >= 40 years

Exclusion criteria

Exclusion Criteria:

  • Exacerbation of 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; ≤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 (other than skin)
  • Medical conditions that limit exercise on an upright stationary bicycle (e.g. severe osteoarthritis, imbalance/gait instability, etc.)
  • Pregnancy
  • \<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, of \<20%
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    COPD

    Participants will complete testing at rest and during moderate- and high-intensity exercise to identify patterns of right ventricular responses.

    Behavioral: Exercise

Interventions

  • BehavioralExercise

    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.

06

What researchers measure

Primary outcomes

  1. Right ventricular contractility measured by transthoracic echocardiography

    Global longitudinal strain, measured in absolute percent

    Time frame: Up to 1 hour

Secondary outcomes

  1. Right ventricular contractility measured by conductance catheter

    Maximum rate of pressure change, dP/dtmax in mmHg/sec

    Time frame: Up to 1 hour

  2. Right ventricular systolic function measured by transthoracic echocardiography

    Fractional area change on transthoracic echocardiography, measured in percent

    Time frame: Up to 1 hour

  3. Right ventricular systolic function measured by transthoracic echocardiography

    Tricuspid annular plane systolic excursion on transthoracic echocardiography, measured in centimeters

    Time frame: Up to 1 hour

  4. 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

    Time frame: Up to 1 hour

  5. Maximum oxygen consumption (VO2max)

    In L/min

    Time frame: Up to 1 hour

  6. Plasma acylcarnitines measured via ultra-high-performance liquid chromatography coupled to mass spectrometry

    Peak intensity, measured as arbitrary units

    Time frame: Up to 1 hour

  7. Physical activity measured by activity monitor

    Time spent in moderate or vigorous activity in absolute percent

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05896579
Responsible party
Sponsor
First posted
Jun 9, 2023
Start date
Aug 22, 2023
Primary completion
May 2030 (estimated)
Completion
Aug 2030 (estimated)
Last update
May 8, 2026

Study contacts

Lindsay Forbes, MD
Contact
lindsay.forbes@cuanschutz.edu
(303)724-4020
Lindsay Forbes, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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