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Right Side of Heart Function After Lung Surgery

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ClinicalTrials.gov Identifier: NCT01892800
Recruitment Status : Unknown
Verified May 2016 by Dr Ben Shelley, University of Glasgow.
Recruitment status was:  Active, not recruiting
First Posted : July 4, 2013
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
Golden Jubilee National Hospital
Information provided by (Responsible Party):
Dr Ben Shelley, University of Glasgow

Brief Summary:
The purpose of this study is explore the impact of lung cancer surgery on the function of the right side of the heart.

Condition or disease Intervention/treatment
Lung Cancer Ventricular Failure, Right Procedure: Lung resection

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.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pulmonary Vascular / Right Ventricular Response to Lung Resection
Study Start Date : August 2013
Actual Primary Completion Date : September 2014
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Study population - lung resection
Patients with suspected lung cancer undergoing lung resection by anatomic lobectomy
Procedure: Lung resection
Other Name: Pulmonary lobectomy




Primary Outcome Measures :
  1. Right ventricular ejection fraction [ Time Frame: 3 days ]
    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.


Secondary Outcome Measures :
  1. Association between RVEF and contractility / loading indices [ Time Frame: 3 days ]

    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.


  2. RVEF vs LVEF [ Time Frame: 3 days ]
    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.

  3. Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF [ Time Frame: 3 days ]

    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)).


  4. Association between RVEF and functional status [ Time Frame: 3 months and 1 year ]
    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.


Biospecimen Retention:   Samples Without DNA
Blood Endo-bronchial aspirate


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective observational cohort study in 25 patients presenting for lobectomy for resection of primary lung cancer
Criteria

Inclusion Criteria:

  1. Provision of informed consent
  2. Age >16 years
  3. Planned elective lung resection by lobectomy

Exclusion Criteria:

  1. Pregnancy
  2. On-going participation in any investigational research which could undermine the scientific basis of the study
  3. 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

  4. Wedge / segmental / sub-lobar lung resection
  5. Pneumonectomy
  6. Isolated right middle lobectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892800


Locations
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United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom
Sponsors and Collaborators
University of Glasgow
Golden Jubilee National Hospital
Investigators
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Principal Investigator: Ben Shelley, MB ChB University of Glasgow

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Ben Shelley, Clinical Research Fellow, University of Glasgow
ClinicalTrials.gov Identifier: NCT01892800     History of Changes
Other Study ID Numbers: 1-shelly
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Keywords provided by Dr Ben Shelley, University of Glasgow:
Lung Cancer
Ventricular function, Right
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases