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Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

Primary Purpose

Cardiotoxicity

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Trimetazidine
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiotoxicity focused on measuring Trimetazidine, Radiation-induced heart damage, GLS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    experimental group

    control group

    Arm Description

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

    No intervention

    Outcomes

    Primary Outcome Measures

    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%.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    May 27, 2021
    Last Updated
    June 17, 2021
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04939857
    Brief Title
    Effect of Trimetazidine on Radiotherapy-induced Heart Damage.
    Official Title
    Effect of Trimetazidine on Radiotherapy-induced Heart Damage in Lung Tumor Patients Treated With Stereotactic Body Radiotherapy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 25, 2021 (Anticipated)
    Primary Completion Date
    July 30, 2022 (Anticipated)
    Study Completion Date
    August 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiotoxicity
    Keywords
    Trimetazidine, Radiation-induced heart damage, GLS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    Trimetazidine was given 2 weeks before radiotherapy, 20 mg each time, three times a day for 3 months.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Trimetazidine
    Intervention Description
    The experimental group will be treated with trimetazidine, and the control group will not be intervened
    Primary Outcome Measure Information:
    Title
    global longitudinal strain-A parameter of two dimensional speckle tracking echocardiography
    Description
    The primary outcome of the trial was a decrease in global longitudinal strain ≥10%.
    Time Frame
    pre-radiotherapy, 12 months after radiotherapy
    Secondary Outcome Measure Information:
    Title
    Rate of major adverse cardiovascular events
    Description
    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.
    Time Frame
    pre-radiotherapy, after completion of radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, and 12 months after radiotherapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dan Zhu, doctor
    Phone
    +8613810103532
    Email
    Andrea_zhu@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tingcui Li, doctor
    Phone
    +8618801236290
    Email
    tingcui2019@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan Zhu, doctor
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Trimetazidine on Radiotherapy-induced Heart Damage.

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