Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Trimetazidine on Radiotherapy-induced Heart Damage in Lung Tumor Patients Treated With Stereotactic Body Radiotherapy.

Conditions
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Cardiotoxicity

Intervention / Treatment
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* Drug: Trimetazidine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Trimetazidine was given 2 weeks before radiotherapy, 20 mg each time, three times a day for 3 months. | Drug: Trimetazidine<br>* The experimental group will be treated with trimetazidine, and the control group will not be intervened<br>|
| No Intervention: control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global longitudinal strain-A parameter of two dimensional speckle tracking echocardiography | The primary outcome of the trial was a decrease in global longitudinal strain ≥10%. | pre-radiotherapy, 12 months after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major adverse cardiovascular events | 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. | pre-radiotherapy, after completion of radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, and 12 months after radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trimetazidine, Radiation-induced heart damage, GLS