Anthracycline Induced Cardiotoxicity Clinical Trial
Official title:
Early Detection of Late Anthracycline Induced Cardiotoxicity in Survivors of Childhood Malignancy
Verified date | February 2024 |
Source | Queen's University, Belfast |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Anthracyclines treat up to 60% of childhood malignancies with remarkable improvements survival rates. Unfortunately anthracyclines are associated with an increased cardiomyopathy risk. One study showed an almost six-fold greater risk of developing cardiomyopathy compared to sibling controls. A retrospective pilot study showed evidence of subclinical dysfunction (including impaired global longitudinal strain) in 42/52 childhood cancer survivors. There is limited research in this area, therefore current guidelines are based on expert opinion alone and lack consensus. Current methods of detection diagnose cardiomyopathy at an irreversible stage i.e. when the compensatory mechanisms are exhausted and the left ventricular ejection fraction impaired. Small trials have shown that early treatment with standard heart failure therapy may reverse damage, further validation is however required in this cohort. Newer techniques such as tissue doppler and strain rate imaging have shown promise for early prediction of cardiomyopathy in adult studies. Biomarkers such as troponin and NT-proBNP have also shown a correlation with cardiomyopathy. This study (n=208) aims to use echocardiography, strain imaging, holter monitoring and MRI for early detection of cardiomyopathy. Biomarkers, both currently used (for example, troponin and NTproBNP,) and more novel (for example, IL6, MPO, and sST2) will be assessed to see if early cardiomyopathy can be predicted. This study will explore biomarker discovery by analysing an age/gender matched subgroup for the top differentially expressed microRNA and protein biomarkers. Selected biomarkers will then be validated in a larger cohort.
Status | Active, not recruiting |
Enrollment | 103 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: -Male and female patients over the age of 18 who have received at least moderate (100mg/m2) anthracycline chemotherapy as a child (<16 years). Exclusion Criteria: - patients born with complex heart disease - patients who would not be safely able to have a magnetic resonance imaging scan - patients who cannot give consent - patients under the age of 18 or who have had less than a moderate dose of anthracycline |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast Health and Social Care Trust | Belfast |
Lead Sponsor | Collaborator |
---|---|
Queen's University, Belfast |
United Kingdom,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiotoxicity | Number of participants with anthracycline related cardiotoxicity as defined by the British Society of Echocardiography and British Cardio-Oncology Society guidelines | 2 years | |
Secondary | Incidence of myocardial injury | Levels of high sensitivity troponin T and NT-proBNP | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02053974 -
Spironolactone Against Anthracycline-induced Cardiomyopathy
|
Phase 4 |