Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiotoxicity
• Intervention / Treatment: Drug: Trimetazidine

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Dan Zhu, doctor; Phone Number: +8613810103532; Email: Andrea_zhu@163.com
• Study Contact Backup: Name: Tingcui Li, doctor; Phone Number: +8618801236290; Email: tingcui2019@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Dan Zhu, doctor, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 25, 2021
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Trimetazidine, Radiation-induced heart damage, GLS
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity; Vasodilator Agents; Trimetazidine
• Other Study ID Numbers: PKU Third Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No