search
Back to results

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

Primary Purpose

COPD, Pulmonary Hypertension, Right Ventricular Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 obtained within 3 years of enrollment and not during an acute exacerbation of COPD Exclusion Criteria: 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 >6 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 ≤45%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than trace in severity; tricuspid regurgitation greater than mild in severity; diabetes with HbA1c >7.5%) Volume overload (jugular vascular distension or greater than trace peripheral edema) Interstitial lung disease Untreated obstructive sleep apnea Active malignancy Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, etc.) Already engaged in routine exercise training (>30 minutes at >3 METs 3 times/week or more) Pregnancy Body mass index <18.5 or >35 Hematocrit <32% or >55% Contraindication to CMR (e.g. metallic or electrical implants, devices, or foreign bodies; severe renal insufficiency with estimated glomerular filtration rate <30 mL/min/1.73 m2) 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, unwillingness to comply with exercise gym COVID precautions, including being up-to-date on COVID vaccination (primary series plus one booster, if eligible)

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COPD with pulmonary artery enlargement

Arm Description

Participants will complete testing 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.

Outcomes

Primary Outcome Measures

Right ventricular-arterial coupling measured by conductance catheter
Ratio of end-systolic elastance to effective arterial elastance (Ees/EA)

Secondary Outcome Measures

Mean pulmonary artery pressure measured by pulmonary artery catheter
In mmHg
Cardiac output measured by pulmonary artery catheter
In L/min, calculated by Fick equation
Right ventricular contractility measured by conductance catheter
Maximum rate of pressure change, dP/dtmax in mmHg/sec
Right ventricular lusitropy measured by conductance catheter
Minimum rate of pressure change, dP/dtmin in mmHg/sec
Right ventricular energetics, measured by conductance catheter
Stroke work in mmHg*mL
Right ventricular ejection fraction by cardiac magnetic resonance imaging
In %
Right ventricular non-invasive ventricular-vascular coupling ratio by cardiac magnetic resonance imaging
Ratio of stroke volume to end-systolic volume
Maximum oxygen consumption (VO2max)
In L/min
Red blood cell acylcarnitine 10:0 measured by peripheral venous metabolomics(ultra-high performance liquid chromatography coupled to mass spectrometry)
Relative ion count
Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics(ultra-high performance liquid chromatography coupled to mass spectrometry)
Relative ion count
Health-related quality of life by COPD Assessment Test (CAT) questionnaire
Units, range 0-40 with greater scores indicating greater impairment in quality of life

Full Information

First Posted
May 31, 2023
Last Updated
July 24, 2023
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT05896579
Brief Title
Identifying Right Ventricular Dysfunction in COPD Through Right Heart Catheterization, Imaging and Exercise
Official Title
Identifying Patterns of Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Artery Enlargement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2023 (Anticipated)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pulmonary Hypertension, Right Ventricular Dysfunction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Study participants will undergo testing to identify patterns of right ventricular dysfunction. If a study participant decides to participate in exercise training, the participant will complete an exercise training intervention followed by repeat testing to determine impact of exercise training on right ventricular dysfunction.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPD with pulmonary artery enlargement
Arm Type
Experimental
Arm Description
Participants will complete testing 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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Exercise training will include supervised high-intensity interval training for ~35 minutes 3x/week on an upright stationary bicycle and unsupervised continuous aerobic exercise for ~30 minutes 2x/week.
Primary Outcome Measure Information:
Title
Right ventricular-arterial coupling measured by conductance catheter
Description
Ratio of end-systolic elastance to effective arterial elastance (Ees/EA)
Time Frame
Up to 1 hour
Secondary Outcome Measure Information:
Title
Mean pulmonary artery pressure measured by pulmonary artery catheter
Description
In mmHg
Time Frame
Up to 1 hour
Title
Cardiac output measured by pulmonary artery catheter
Description
In L/min, calculated by Fick equation
Time Frame
Up to 1 hour
Title
Right ventricular contractility measured by conductance catheter
Description
Maximum rate of pressure change, dP/dtmax in mmHg/sec
Time Frame
Up to 1 hour
Title
Right ventricular lusitropy measured by conductance catheter
Description
Minimum rate of pressure change, dP/dtmin in mmHg/sec
Time Frame
Up to 1 hour
Title
Right ventricular energetics, measured by conductance catheter
Description
Stroke work in mmHg*mL
Time Frame
Up to 1 hour
Title
Right ventricular ejection fraction by cardiac magnetic resonance imaging
Description
In %
Time Frame
Up to 1 hour
Title
Right ventricular non-invasive ventricular-vascular coupling ratio by cardiac magnetic resonance imaging
Description
Ratio of stroke volume to end-systolic volume
Time Frame
Up to 1 hour
Title
Maximum oxygen consumption (VO2max)
Description
In L/min
Time Frame
Up to 1 hour
Title
Red blood cell acylcarnitine 10:0 measured by peripheral venous metabolomics(ultra-high performance liquid chromatography coupled to mass spectrometry)
Description
Relative ion count
Time Frame
Up to 1 hour
Title
Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics(ultra-high performance liquid chromatography coupled to mass spectrometry)
Description
Relative ion count
Time Frame
Up to 1 hour
Title
Health-related quality of life by COPD Assessment Test (CAT) questionnaire
Description
Units, range 0-40 with greater scores indicating greater impairment in quality of life
Time Frame
Up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 obtained within 3 years of enrollment and not during an acute exacerbation of COPD Exclusion Criteria: 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 >6 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 ≤45%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than trace in severity; tricuspid regurgitation greater than mild in severity; diabetes with HbA1c >7.5%) Volume overload (jugular vascular distension or greater than trace peripheral edema) Interstitial lung disease Untreated obstructive sleep apnea Active malignancy Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, etc.) Already engaged in routine exercise training (>30 minutes at >3 METs 3 times/week or more) Pregnancy Body mass index <18.5 or >35 Hematocrit <32% or >55% Contraindication to CMR (e.g. metallic or electrical implants, devices, or foreign bodies; severe renal insufficiency with estimated glomerular filtration rate <30 mL/min/1.73 m2) 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, unwillingness to comply with exercise gym COVID precautions, including being up-to-date on COVID vaccination (primary series plus one booster, if eligible)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Forbes, MD
Phone
(720)892-6017
Email
lindsay.forbes@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
William Cornwell, MD, MSCS
Email
william.cornwell@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Forbes, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay "Shelley" Forbes, MD
Phone
720-892-6017
Email
lindsay.forbes@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs