Clinical trial NCT01892800: Right Side of Heart Function After Lung Surgery
Official title: The Pulmonary Vascular / Right Ventricular Response to Lung Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Ventricular Failure, Right
Keywords: Lung Cancer
Ventricular function, Right
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Golden Jubilee National Hospital
First posted: 2013-07-04
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective observational cohort study in 25 patients presenting for lobectomy for resection of primary lung cancer

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.

Eligibility 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

Primary outcomes:
measure: Right ventricular ejection fraction
timeFrame: 3 days
Secondary outcomes:
measure: Association between RVEF and contractility / loading indices
timeFrame: 3 days
measure: RVEF vs LVEF
timeFrame: 3 days
measure: Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF
timeFrame: 3 days
measure: Association between RVEF and functional status
timeFrame: 3 months and 1 year
Other outcomes:
Locations:
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
Study officials:
affiliation: University of Glasgow
name: Ben Shelley, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.