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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019417
Receipt No. R000022378
Scientific Title Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes
Date of disclosure of the study information 2015/10/20
Last modified on 2015/10/21

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Basic information
Public title Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes

Acronym Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes (SUCCOUR Study)
Scientific Title Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes

Scientific Title:Acronym Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes (SUCCOUR Study)
Region
Japan Asia(except Japan) North America
Australia Europe

Condition
Condition Cancer therapeutics-related cardiac dysfunction
Classification by specialty
Cardiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this study is to show that information from strain imaging leads to the use of adjunctive therapy that will limit the development of reduced ejection fraction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary study end-point is change in 3D ejection fraction from baseline to up to three years, as determined by a blinded core laboratory and analyzed on an intention-to-treat basis according to random study group allocation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Patients coming to the echo lab for echo surveillance of LV function will be randomized to provision of global strain (GLS) and ejection fraction (EF) or receive standard EF alone.
In the conventional imaging arm, if there is a symptomatic drop of more than 5% of ejection fraction, or a 10% asymptomatic drop of ejection fraction to EF <55%, the patient will be referred for initiation and titration of heart failure therapy (beta blockers and ACE inhibitors).
Interventions/Control_2 In the advanced cardiac imaging arm, if there is a reduction of global longitudinal strain by >12% in any of the follow-up echocardiograms (3,6,9,12), as compared to baseline, the patient will be referred for initiation and titration of heart failure therapy (beta blockers and ACE inhibitors).
the process of randomization will involve imaging strategy rather than therapy (all patients with LV dysfunction will be given the same therapy) the difference will relate to as what level of LV impairment this is administered
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients actively undergoing chemotherapy at increased risk of cardiotoxicity;
use of anthracycline WITH current (but not necessarily concurrent)
trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR
tyrosine kinase inhibitors (eg sunitinib) OR
cumulative anthracycline dose >450g/m2 of doxorubicin, or equivalent other anthracycline cumulative dose (eg for epirubicin >900g/m2).OR
increased risk of HF (any two of age >65y, type 2 diabetes mellitus, hypertension, previous cardiac injury eg. myocardial infarction)
2. Live within a geographically accessible area for follow-up
3. Are able and willing to provide written informed consent to participate in the study (this includes the ability to communicate fluently with the investigator and that the patient is mentally competent)
Key exclusion criteria 1. Unable to provide written informed consent to participate in this study
2. Participating in another clinical research trial where randomized treatment would be unacceptable
3. Valvular stenosis or regurgitation of >moderate severity
4. History of previous heart failure (baseline NYHA >2)
5. Systolic BP <110mmHg
6. Pulse <60/minute
7. Inability to acquire interpretable images (identified from baseline echo)
8. Contraindications/Intolerance to beta blockers or ACE inhibitors
9. Existing therapy with both beta blockers and ACE inhibitors
10. Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
Target sample size 320

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Professor Tom Marwick
Organization Menzies Institute for Medical Research
Division name Cardiao-Metabolic Disease
Zip code
Address 17 Livepool Street, Hobart, TAS, Australia, 7000
TEL +61-3-6226-7703
Email tom.marwick@utas.edu.au

Public contact
Name of contact person
1st name
Middle name
Last name Professor Tom Marwick
Organization Menzies Institute for Medical Research
Division name Cardiao-Metabolic Disease
Zip code
Address 17 Liverpool Street, Hobart, TAS, Australia, 7000
TEL +61-3-6226-7703
Homepage URL
Email tom.marwick@utas.edu.au

Sponsor
Institute Menzies Institute for Medical Research
Institute
Department

Funding Source
Organization GE Medical Systems
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 ACTRN12614000341628
Org. issuing International ID_1 Australian New Zealand Clinical Trials Registry(ANZCTR)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 20 Day
Last modified on
2015 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022378

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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