UMIN-CTR Clinical Trial

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

Cancer therapeutics-related cardiac dysfunction

Classification by specialty

Cardiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Menzies Institute for Medical Research

Institute

Department

Personal name

Organization

GE Medical Systems

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2015

Year

10

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

10

Month

20

Day

Last modified on

2015

Year

10

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022378