UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022984 |
|---|---|
| Receipt number | R000026423 |
| Scientific Title | A cohort study of anthracycline-induced cardiotoxicity |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2025/01/07 13:19:22 |
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Basic information
Public title
A cohort study of anthracycline-induced cardiotoxicity
Acronym
A cohort study of anthracycline-induced cardiotoxicity
Scientific Title
A cohort study of anthracycline-induced cardiotoxicity
Scientific Title:Acronym
A cohort study of anthracycline-induced cardiotoxicity
Region
| Japan |
Condition
Condition
All patients scheduled for anthracycline-containing therapy for various kinds of tumors
Classification by specialty
| Cardiology | Hematology and clinical oncology | Breast surgery |
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of anthracycline-induced cardiotoxicity and find predictive factors markers in cancer patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of cardiotoxicity defined as a reduction in left ventricular ejection fraction (LVEF) >10 percentage points from baseline and <50%
Key secondary outcomes
All cause death, the following cardiac events (cardiac death, acute pulmonary edema, acute coronary syndromes, llife-threatening arrhythmias), the recovery from cadiotoxicity after the initiation of heart failure treatment defined as EF>50%
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Echocardiac examination (before & during anthracycline treatment, after 3, 6, 9, 12, 18, 24 month)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) malignancy patients in the face of with anthracycline chemotherapy
2) age more than 20 years old
3) EF > 50%
4) life expectancy of > 1year
5) written informed consent
Key exclusion criteria
1) cases with valuvular heart disease, gongenital heart disease, and cardiomyopathy
2) pregnant or lactating women
3) psychotic disorder
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Tajiri |
Organization
University of Tsukuba Hospital
Division name
Cardiovascular Division
Zip code
305-8576
Address
Amakubo 2-1-1, Tsukuba, Ibaraki
TEL
029-853-3143
ktajiri@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Tajiri |
Organization
University of Tsukuba Hospital
Division name
Cardiovascular Division
Zip code
305-8576
Address
Amakubo 2-1-1, Tsukuba, Ibaraki
TEL
029-853-3143
Homepage URL
ktajiri@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba
Tel
029-853-3914
rinshokenkyu@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
筑波大学附属病院（茨城県）、水戸協同病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2077-0383/10/7/1370
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/88/5/88_CJ-24-0065/_html/-char/en
Number of participants that the trial has enrolled
500
Results
383 patients completed the 2-year follow-up; 42 patients developed cardiotoxicity. Increases in troponin T (TnT) and B-type natriuretic peptide (BNP) and relative reductions in the LV global longitudinal strain (LV GLS) and LA reservoir strain (LASr) at 3 months were independently associated with subsequent cardiotoxicity. A risk score containing smoking, prior cardiovascular disease, TnT>0.019 ng/mL, BNP>31.1 pg/mL, and relative declines in LV GLS (>6.5%) and LASr (>7.5%) was generated.
Results date posted
| 2025 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study cohort included patients with cancer who were receiving anthracycline chemotherapy and prospectively enrolled in the AIC registry between July 2016 and October 2021.
Participant flow
Patients were evaluated before initiating anthracycline therapy, every 3 months during the first year of anthracycline treatment and every 6 months during the second year.
Adverse events
Not applicable
Outcome measures
Cardiotoxicity occurring during the 2-year follow-up period was the primary endpoint, defined as a decrease in LVEF of at least 10 percentage points from baseline and less than 55%, according to Cardiac Review and Evaluation Committee criteria.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026423
