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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension; COPD; Right Ventricular Dysfunction
• Intervention / Treatment: Behavioral: Exercise training

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsay Forbes, MD; Phone Number: (720)892-6017; Email: lindsay.forbes@cuanschutz.edu
• Study Contact Backup: Name: William Cornwell, MD, MSCS; Email: william.cornwell@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Lindsay "Shelley" Forbes, MD; Phone Number: 720-892-6017; Email: lindsay.forbes@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 >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 ≤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.)
• Pregnancy
• Body mass index <18.5 or >35
• Hematocrit <32% 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD with pulmonary artery enlargement; 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.	Behavioral: Exercise training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular-arterial coupling measured by conductance catheter	Ratio of end-systolic elastance to effective arterial elastance (Ees/EA)	Up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics (ultra-high performance liquid chromatography coupled to mass spectrometry)	Relative ion count	Up to 1 hour
Mean pulmonary artery pressure measured by pulmonary artery catheter	In mmHg	Up to 1 hour
Cardiac output measured by pulmonary artery catheter	In L/min, calculated by Fick equation	Up to 1 hour
Right ventricular contractility measured by conductance catheter	Maximum rate of pressure change, dP/dtmax in mmHg/sec	Up to 1 hour
Right ventricular lusitropy measured by conductance catheter	Minimum rate of pressure change, dP/dtmin in mmHg/sec	Up to 1 hour
Right ventricular energetics, measured by conductance catheter	Stroke work in mmHg*mL	Up to 1 hour
Maximum oxygen consumption (VO2max)	In L/min	Up to 1 hour
Red blood cell acylcarnitine 10:0 measured by peripheral venous metabolomics(ultra-high performance liquid chromatography coupled to mass spectrometry)	Relative ion count	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	Up to 1 hour
Right to left ventricle diameter ratio measured by computed tomography	Ratio of right ventricle diameter to left ventricle diameter	Up to 1 hour
Distal pulmonary vascular pruning measured by computed tomography	Ratio of total volume of small pulmonary blood vessels defined by cross-sectional area <5 mm2 to total volume of all pulmonary blood vessels	Up to 1 hour

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Lindsay Forbes, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: 23-0516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No