Lung CancerNCT01892800
Right Side of Heart Function After Lung Surgery
An observational study of Lung Cancer and Ventricular Failure, Right, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Cancer, Ventricular Failure, Right
- What is being tested?
- Lung resection
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospective observational cohort study in 25 patients presenting for lobectomy for resection of primary lung cancer
Who may be able to join
- Provision of informed consent
- Age >16 years
- Planned elective lung resection by lobectomy
Who cannot join
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Contraindications to magnetic resonance imaging:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pulmonary Vascular / Right Ventricular Response to Lung Resection
The purpose of this study is explore the impact of lung cancer surgery on the function of the right side of the heart.
Read the 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.
- Conditions
- Lung Cancer, Ventricular Failure, Right
- Being tested
- Lung resection
- Keywords
- Lung Cancer, Ventricular function, Right
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung resectionProcedure or surgery
Also called Pulmonary lobectomy
| Study group | Role | What they receive |
|---|---|---|
| Study population - lung resection | Patients with suspected lung cancer undergoing lung resection by anatomic lobectomy Receives: Procedure: Lung resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (4)
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.
Measured: 3 days
RVEF vs LVEF
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.
Measured: 3 days
Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF
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)).
Measured: 3 days
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.
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Responsible party
- Principal investigator, Dr Ben Shelley, University of Glasgow
- Investigators
- Ben Shelley, MB ChB, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892800
- Sponsor's protocol ID
- 1-shelly
- Status last verified
- May 2016
- First submitted
- 1 Jul 2013
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 36115714Young 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.
PubMed 30753496
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pulmonary Vascular / Right Ventricular Response to Lung Resection
- ClinicalTrials.gov ID
- NCT01892800
- Acronym / sponsor ID
- 1-shelly
- Conditions
- Lung Cancer, Ventricular Failure, Right
- Keywords
- Lung Cancer, Ventricular function, Right
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population - lung resection | – | Procedure: Lung resectionPatients with suspected lung cancer undergoing lung resection by anatomic lobectomy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective observational cohort study in 25 patients presenting for lobectomy for resection of primary lung cancer
Key inclusion criteria (3 listed)
- Provision of informed consent
- Age >16 years
- Planned elective lung resection by lobectomy
Key exclusion criteria (7 listed)
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Contraindications to magnetic resonance imaging:
- Wedge / segmental / sub-lobar lung resection
- Pneumonectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung resectionAlso: Pulmonary lobectomy | Procedure or surgery | Study population - lung resection |
Primary outcome
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.
4 secondary outcomes
Association between RVEF and contractility / loading indices
Time frame: 3 days
RVEF vs LVEF
Time frame: 3 days
Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF
Time frame: 3 days
Association between RVEF and functional status
Time frame: 3 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 36115714Glass 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.
- Derived from this study: PubMed 30753496Young 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Shelley, MB ChB principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Ventricular Failure, Right, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular ejection fraction (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892800, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.