Right Side of Heart Function After Lung Surgery

• Conditions: Lung Cancer; Ventricular Failure, Right
• Interventions: Procedure: Lung resection

• Registration Number: NCT01892800
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-04
• Study Start: 2013-08
• Primary Completion: 2014-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-16
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population - lung resection	Lung resection	Patients with suspected lung cancer undergoing lung resection by anatomic lobectomy

Primary Outcome Measures

Name	Time	Method
Right ventricular ejection fraction	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

Name	Time	Method
Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF	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)).
RVEF vs LVEF	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.
Association between RVEF and contractility / loading indices	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.
Association between RVEF and functional status	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.

Trial Locations

Locations (1)

Golden Jubilee National Hospital; 🇬🇧 Clydebank, United Kingdom