RECRUITING

Identifying Right Ventricular Dysfunction in COPD Through Right Heart Catheterization, Imaging and Exercise

Conditions

COPD Pulmonary Hypertension Right Ventricular Dysfunction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 to pulmonary hypertension (high pressure in the lungs) during rest and exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.

Official Title

Identifying Patterns of Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Artery Enlargement

Quick Facts

Study Start:2023-08-22

Study Completion:2030-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05896579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \[FEV1/FVC\] \<0.7) • Pulmonary artery enlargement determined by pulmonary artery-to-aorta ratio \>1 or \>30 mm on most recent CT	* Exacerbation of COPD or use of systemic corticosteroids 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 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 mildin severity; tricuspid regurgitation greater than moderate in severity; diabetes with HbA1c \>8.5%) * Volume overload (jugular vascular distension or greater than trace peripheral edema) * Interstitial lung disease * Untreated severe obstructive sleep apnea * Active malignancy * Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, etc.) * Pregnancy * Body mass index \<18 or \>35 * Hematocrit \<25% or \>55% * For optional Part 2 i.e. exercise training and Visit 2, residence \>90 miles from University of Colorado Anschutz Medical Campus or unwillingness/inability to attend exercise training sessions for approximately 35 minutes 3x/week for 12 weeks * For optional Part 2 i.e. exercise training and Visit 2, already engaged in routine exercise training (\>30 minutes at \>3 METs 3 times/week or more)

Inclusion Criteria

Exclusion Criteria

* COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \[FEV1/FVC\] \<0.7) • Pulmonary artery enlargement determined by pulmonary artery-to-aorta ratio \>1 or \>30 mm on most recent CT

* Exacerbation of COPD or use of systemic corticosteroids 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 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 mildin severity; tricuspid regurgitation greater than moderate in severity; diabetes with HbA1c \>8.5%)
* Volume overload (jugular vascular distension or greater than trace peripheral edema)
* Interstitial lung disease
* Untreated severe obstructive sleep apnea
* Active malignancy
* Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, etc.)
* Pregnancy
* Body mass index \<18 or \>35
* Hematocrit \<25% or \>55%
* For optional Part 2 i.e. exercise training and Visit 2, residence \>90 miles from University of Colorado Anschutz Medical Campus or unwillingness/inability to attend exercise training sessions for approximately 35 minutes 3x/week for 12 weeks
* For optional Part 2 i.e. exercise training and Visit 2, already engaged in routine exercise training (\>30 minutes at \>3 METs 3 times/week or more)

Contacts and Locations

Study Contact

Lindsay Forbes, MD

CONTACT

(720)892-6017

lindsay.forbes@cuanschutz.edu

William Cornwell, MD, MSCS

CONTACT

william.cornwell@cuanschutz.edu

Principal Investigator

Lindsay Forbes, MD

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Lindsay Forbes, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-22

Study Completion Date2030-07

Study Record Updates

Study Start Date2023-08-22

Study Completion Date2030-07

Terms related to this study

Additional Relevant MeSH Terms

COPD
Pulmonary Hypertension
Right Ventricular Dysfunction