Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

Cardiotoxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04939857
• Other study ID #: PKU Third Hospital
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 25, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Dan Zhu, doctor
• Phone: +8613810103532
• Email: Andrea_zhu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiotoxicity

Intervention

Drug:
• Trimetazidine
The experimental group will be treated with trimetazidine, and the control group will not be intervened

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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