Defining Robust Predictors of Chemotherapy Related Cardiotoxicity

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05159479

Enrollment

600

Registered

2021-12-16

Start date

2021-10-13

Completion date

2024-07-01

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity, Gastrointestinal Neoplasms

Keywords

Fluoropyrimidine, Cardiotoxicity, Cardio-oncology

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of fluoropyrimidine induced cardiotoxicity (FIC)	12 months	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.
Relationship of baseline cardiovascular risk with FIC	12 months	Baseline cardiovascular risk assessed using QRISK3 cardiovascular risk calculator

Secondary

Measure	Time frame	Description
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)	—
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)	—
Cardiovascular symptom assessment	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)	Using modified seattle angina questionnaire

Countries

United Kingdom

Contacts

Primary ContactAderonke Abiodun

aderonketemilade.abiodun@nhs.net07737138851

Outcome results