Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

Sponsor

Peking University Third Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04939857

Collaborator

(none)

Enrollment

Arms

14.2

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiotoxicity	Drug: Trimetazidine	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 25, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: control group No intervention

Arm

Intervention/Treatment

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

No Intervention: control group

No intervention

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University Third Hospital

Investigators

Study Chair: Dan Zhu, doctor, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT04939857

Other Study ID Numbers:

PKU Third Hospital

First Posted:

Jun 25, 2021

Last Update Posted:

Jun 25, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking University Third Hospital

Trimetazidine, Radiation-induced heart damage, GLS

Additional relevant MeSH terms:

Cardiotoxicity

Trimetazidine

Study Results

No Results Posted as of Jun 25, 2021