Cardiotoxicity
Conditions
Keywords
Trimetazidine, Radiation-induced heart damage, GLS
Brief summary
This is a randomized controlled trial. 80 patients with thoracic radiotherapy will be included. Participants will be randomly divided into experimental group or control group. Before radiotherapy, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, electrocardiogram (ECG), and hs-CRP will be detected. During subsequent follow-up, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, ECG, and hs-CRP will be collected at every follow-up time.
Detailed description
This is a randomized controlled trial. 80 patients with thoracic radiotherapy will be included in Peking University Third Hospital from May 15, 2021 to August 31, 2022. Participants will be randomly divided into experimental group or control group. Before radiotherapy, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, electrocardiogram (ECG), and hs-CRP will be detected. All participants will be followed up after completion of RT, 3 months after RT, 6 months after RT, and 12 months after RT. During subsequent follow-up, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, ECG, and hs-CRP will be collected at every follow-up time.
Interventions
DRUGTrimetazidine
The experimental group will be treated with trimetazidine, and the control group will not be intervened
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* lung tumor patients; 18-80 years old; will be treated by stereotactic body radiotherapy
Exclusion criteria
* Prior radiotherapy; ACS; heart failure (NYHA III-IV); arrhythmia requiring intervention; echocardiographic images that could not be satisfactorily obtained; significant valvular heart disease (defined as more than mild valvular regurgitation or stenosis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| global longitudinal strain-A parameter of two dimensional speckle tracking echocardiography | pre-radiotherapy, 12 months after radiotherapy | The primary outcome of the trial was a decrease in global longitudinal strain ≥10%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of major adverse cardiovascular events | pre-radiotherapy, after completion of radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, and 12 months after radiotherapy | Proportion of patients with major adverse cardiovascular events (MACE) in total participants. MACE was defined as unstable angina, new arrhythmia, acute myocardial infarction, heart failure, valvular heart disease, acute pericarditis, and cardiac death in this study. |
Contacts
Primary ContactDan Zhu, doctor
Backup ContactTingcui Li, doctor
Outcome results
None listed