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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896579
• Other study ID #: 23-0516
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: June 2028

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Lindsay Forbes, MD
• Phone: (720)892-6017
• Email: lindsay.forbes[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular-arterial coupling measured by conductance catheter	Ratio of end-systolic elastance to effective arterial elastance (Ees/EA)	Up to 1 hour
Secondary	Mean pulmonary artery pressure measured by pulmonary artery catheter	In mmHg	Up to 1 hour
Secondary	Cardiac output measured by pulmonary artery catheter	In L/min, calculated by Fick equation	Up to 1 hour
Secondary	Right ventricular contractility measured by conductance catheter	Maximum rate of pressure change, dP/dtmax in mmHg/sec	Up to 1 hour
Secondary	Right ventricular lusitropy measured by conductance catheter	Minimum rate of pressure change, dP/dtmin in mmHg/sec	Up to 1 hour
Secondary	Right ventricular energetics, measured by conductance catheter	Stroke work in mmHg*mL	Up to 1 hour
Secondary	Maximum oxygen consumption (VO2max)	In L/min	Up to 1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	Right to left ventricle diameter ratio measured by computed tomography	Ratio of right ventricle diameter to left ventricle diameter	Up to 1 hour
Secondary	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