Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

NCT04939857 | Unknown Phase 2 DMC

• 1 other identifier: PKU Third Hospital
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiotoxicity

Keywords

Trimetazidine, Radiation-induced heart damage, GLS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

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

Drug: Trimetazidine

control group

NO INTERVENTION

No intervention

Interventions

Trimetazidine DRUG

The experimental group will be treated with trimetazidine, and the control group will not be intervened

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• lung tumor patients; 18-80 years old; will be treated by stereotactic body radiotherapy

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Cardiotoxicity

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dan Zhu, doctor

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Dan Zhu, doctor

CONTACT

+8613810103532; Andrea_zhu@163.com

Tingcui Li, doctor

CONTACT

+8618801236290; tingcui2019@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 25, 2021
• Study Start: June 25, 2021
• Primary Completion: July 30, 2022
• Study Completion: August 31, 2022
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share