Right Side of Heart Function After Lung Surgery

Lung Cancer Clinical Trial

Official title:

The Pulmonary Vascular / Right Ventricular Response to Lung Resection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01892800
• Other study ID #: 1-shelly
• Status: Active, not recruiting
• Phase: N/A
• First received: July 1, 2013
• Last updated: May 12, 2016
• Start date: August 2013
• Est. completion date: August 2016

Study information

• Verified date: May 2016
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: August 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Ventricular Failure, Right

Intervention

Procedure:
• Lung resection

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Clydebank

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	Golden Jubilee National Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular ejection fraction	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.	3 days	No
Secondary	Association between RVEF and contractility / loading indices	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	No
Secondary	RVEF vs LVEF	Changes in right-sided cardiac function must be interpreted in the context of left-sided function. ?RVEF will be compared to changes in Left Ventricular Ejection Fraction (LVEF) over the same period.	3 days	No
Secondary	Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ?RVEF	Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ?RVEF.; 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	No
Secondary	Association between RVEF and functional status	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.	3 months and 1 year	No