Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

Phase 2

• Conditions: Cardiotoxicity
• Interventions: Drug: Trimetazidine

• Registration Number: NCT04939857
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study First Submitted: 2021-05-27
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study Start: 2021-06-25
• Study First Posted: 2021-06-25
• Last Update Posted: 2021-06-25
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Trimetazidine	Trimetazidine was given 2 weeks before radiotherapy, 20 mg each time, three times a day for 3 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.