Defining Robust Predictors of Chemotherapy Related Cardiotoxicity

Gastrointestinal Neoplasms Clinical Trial

Official title:

Defining Robust Predictors of Chemotherapy Related Cardiotoxicity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05159479
• Other study ID #: 140342
• Status: Recruiting
• Start date: October 13, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: University College, London
• Contact: Aderonke Abiodun
• Phone: 07737138851
• Email: aderonketemilade.abiodun[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.

Description:

All enrolled participants will undergo baseline cardiovascular risk assessment (using QRISK3 and SCORE 2 risk calculators), cardiac, oncological and medication history. All participants will have serial cardiac symptom assessment, 12 lead ECG and cardiac biomarker assessments(high sensitivity troponin T and NT pro BNP) at baseline, on completion of the first cycle of treatment and post completion of treatment. Participants will be followed up for the development of cardiotoxicity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18

• Consented to receive fluoropyrimidine chemotherapy for GI malignancies (gastro-oesophageal, colorectal, pancreatic)

• Capacity to provide consent

Exclusion Criteria:

• Age <18

• Lacking capacity to consent

Related Conditions & MeSH terms

• Cardiotoxicity
• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Locations

Country	Name	City	State
United Kingdom	St Bartholomews Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of fluoropyrimidine induced cardiotoxicity (FIC)	Fluoropyrimidine induced cardiotoxicity defined as a composite of: Types 1-3 myocardial infarction with troponin >99th percentile upper limit,; Incident myocardial ischaemia (chest pain with or without new inducible perfusion abnormality on perfusion cardiac MRI,; Myocarditis (diagnosed as per European Society of Cardiology Consensus statement); Incident heart failure (HF) diagnosis (symptoms with raised N-terminal pro-B-type natriuretic peptide (NTproBNP )> 400pg/ml or HF hospitalisation),; Incident arrhythmia (excluding isolated ectopy) or sudden cardiac death.	12 months
Primary	Relationship of baseline cardiovascular risk with FIC	Baseline cardiovascular risk assessed using QRISK3 cardiovascular risk calculator	12 months
Primary	Relationship of baseline cardiovascular risk with FIC	Baseline cardiovascular risk assessed using SCORE2 cardiovascular risk calculator	12 months
Secondary	Change in cardiac biomarkers (high sensitivity troponin T)		Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
Secondary	Change in cardiac biomarkers (NT pro BNP)		Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
Secondary	Cardiovascular symptom assessment	Using modified seattle angina questionnaire	Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)