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Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

P

Peking University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Cardiotoxicity

Treatments

Drug: Trimetazidine

Study type

Interventional

Funder types

Other

Identifiers

NCT04939857
PKU Third Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

experimental group
Experimental group
Description:
Trimetazidine was given 2 weeks before radiotherapy, 20 mg each time, three times a day for 3 months.
Treatment:
Drug: Trimetazidine
control group
No Intervention group
Description:
No intervention

Trial contacts and locations

0

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Central trial contact

Dan Zhu, doctor; Tingcui Li, doctor

Data sourced from clinicaltrials.gov

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