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

Not Applicable

Recruiting

• Conditions: Pulmonary Hypertension; COPD; Right Ventricular Dysfunction
• Interventions: Behavioral: Exercise training

• Registration Number: NCT05896579
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Study Start: 2023-08-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-09
• Primary Completion: 2030-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 on most recent CT

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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 ≤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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPD with pulmonary artery enlargement	Exercise training	Participants will complete testing at rest and during exercise 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cardiac output measured by pulmonary artery catheter	Up to 1 hour	In L/min, calculated by Fick equation
Maximum oxygen consumption (VO2max)	Up to 1 hour	In L/min
Red blood cell acylcarnitine 10:0 measured by peripheral venous metabolomics(ultra-high performance liquid chromatography coupled to mass spectrometry)	Up to 1 hour	Relative ion count
Health-related quality of life by Short Form 36 (SF-36) questionnaire	Up to 1 hour	Units, range 0-100 with greater scores indicating a more favorable health state
Mean pulmonary artery pressure measured by pulmonary artery catheter	Up to 1 hour	In mmHg
Right ventricular contractility measured by conductance catheter	Up to 1 hour	Maximum rate of pressure change, dP/dtmax in mmHg/sec
Exercise training safety	4 months	Adverse events, reported or observed
Right to left ventricle diameter ratio measured by computed tomography	Up to 1 hour	Ratio of right ventricle diameter to left ventricle diameter
Right ventricular contractility measured by transthoracic echocardiography	Up to 1 hour	Rate of pressure change, tricuspid dP/dt in mmHg/sec
Right ventricular energetics, measured by conductance catheter	Up to 1 hour	Stroke work in mmHg\*mL
Right ventricular lusitropy measured by conductance catheter	Up to 1 hour	Minimum rate of pressure change, dP/dtmin in mmHg/sec
Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics (ultra-high performance liquid chromatography coupled to mass spectrometry)	Up to 1 hour	Relative ion count
Distal pulmonary vascular pruning measured by computed tomography	Up to 1 hour	Ratio of total volume of small pulmonary blood vessels defined by cross-sectional area \<5 mm2 to total volume of all pulmonary blood vessels
Exercise training feasibility	4 months	Proportion of exercise training sessions completed

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States