- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892800
Right Side of Heart Function After Lung Surgery
The Pulmonary Vascular / Right Ventricular Response to Lung Resection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lung cancer is the second most common cancer in the UK. In suitable cases the best chance of cure is surgical resection. Studies suggest that lung resection is associated with right ventricular (RV) dysfunction, predisposing to complications and post-operative dyspnoea. Studies of RV function following lung resection have been hampered by the limitations of the techniques used. In addition the mechanism of RV dysfunction has remained elusive.
In this prospective observational study the RV response to lung resection will be characterised by sequential assessment of right ventricular ejection fraction (RVEF) measured using cardiovascular magnetic resonance (CMR). CMR is non-invasive, involves no ionising radiation and due to its high spatial resolution is the gold standard for assessing RV volumes. Comprehensive CMR and echocardiographic assessment of the pulmonary vascular - RV axis will allow us to interpret peri-operative changes in RVEF in the context of RV contractility and loading indices. In addition, contemporaneous blood samples will be taken for measurement of biomarkers of myocardial and endothelial dysfunction and systemic inflammation.
With increased understanding of the mechanisms involved, it may be possible to prevent RV dysfunction; reducing complication rates, hospital stay and costs and ameliorating long term dyspnoea.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Clydebank, United Kingdom
- Golden Jubilee National Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Provision of informed consent
- Age >16 years
- Planned elective lung resection by lobectomy
Exclusion Criteria:
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
Contraindications to magnetic resonance imaging:
i. Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. Aneurysm clips iii. Metal injuries to the eye iv. Loose metal in an part of the body
- Wedge / segmental / sub-lobar lung resection
- Pneumonectomy
- Isolated right middle lobectomy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Study population - lung resection
Patients with suspected lung cancer undergoing lung resection by anatomic lobectomy
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Right ventricular ejection fraction
Time Frame: 3 days
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The primary objective of this study is determine whether RVEF falls post-operatively in patients undergoing lung resection.
The primary outcome is RVEF at 3 days post-lung resection compared to pre-operative values determined by CMR.
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3 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between RVEF and contractility / loading indices
Time Frame: 3 days
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Changes in RVEF must be interpreted in the context of changes in RV contractility and loading parameters. Changes in pre-load, contractility, afterload, ventriculo-arterial coupling, diastolic function and the position of the mediastinum could all potentially influence RVEF.The following indices will be subject to assessment as secondary endpoints: Preload - Right ventricular end-diastolic volume (RVEDV) Contractility - Peak systolic strain and strain rate Afterload - Pulmonary artery (PA) distensibility, PA peak velocitly, PA antegrade flow, Estimated PA systolic pressure,Pulmonary artery acceleration time Ventriculo-arterial coupling: Ea/Emax(CMR) Diastolic function: E/A velocity ratio. |
3 days
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RVEF vs LVEF
Time Frame: 3 days
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Changes in right-sided cardiac function must be interpreted in the context of left-sided function.
ΔRVEF will be compared to changes in Left Ventricular Ejection Fraction (LVEF) over the same period.
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3 days
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Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF
Time Frame: 3 days
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Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF. Myocardial dysfunction: Brain natriuretic peptide and high sensitivity Troponin-T. Systemic inflammation: C-reactive protein and Pentraxin 3. Oxidative / Nitrosative stress: Malondialdehyde, nitrate and nitrite (determined in plasma and endobronchial aspirate and the end of surgery). Endothelial dysfunction: Angiopoietin (Ang) 1 & 2, Von Willebrand factor (VWf), E-selectin (ESEL) and soluble intracellular adhesion molecule (sICAM)). |
3 days
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Association between RVEF and functional status
Time Frame: 3 months and 1 year
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Association between RVEFpreop, RVEFpostop, and RVEF3months and functional status by self report and 6-minute walk test (6MWT).
Functional status will be assessed subjectively by written questionnaire.
Scoring will be based on the New York Heart Association (NYHA) classification, WHO performance status classification and health related quality of life scoring by EQ-5D questionnaire.
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3 months and 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ben Shelley, MB ChB, University of Glasgow
Publications and helpful links
General Publications
- Glass A, McCall P, Arthur A, Mangion K, Shelley B. Pulmonary artery wave reflection and right ventricular function after lung resection. Br J Anaesth. 2023 Jan;130(1):e128-e136. doi: 10.1016/j.bja.2022.07.052. Epub 2022 Sep 15.
- Young DJ, McCall PJ, Kirk A, Macfie A, Kinsella J, Shelley BG. B-type natriuretic peptide predicts deterioration in functional capacity following lung resection. Interact Cardiovasc Thorac Surg. 2019 Jun 1;28(6):945-952. doi: 10.1093/icvts/ivz016.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-shelly
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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