UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009522 |
|---|---|
| Receipt number | R000011166 |
| Scientific Title | SCAN-HF study |
| Date of disclosure of the study information | 2012/12/12 |
| Last modified on | 2020/01/15 18:25:29 |
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Basic information
Public title
SCAN-HF study
Acronym
SCAN-HF study: Risk Stratification by Integrated DiagNostics in Patients With Heart Failure
Scientific Title
SCAN-HF study
Scientific Title:Acronym
SCAN-HF study: Risk Stratification by Integrated DiagNostics in Patients With Heart Failure
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the performance of Integrated Diagnostics in stratifying the patients at risk of Heart Failure related hospitalizations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart Failure Hospitalization
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patient has CRT-D indications in Japan.
2. Patient scheduled to be implanted or who has already implanted with CRT-D with OptiVol2.0 within 65 days.
3. Patient has a history of at least one heart failure related hospitalization, or all visit necessitating intravenous diuretic, inotropic, vasodilator, or other parenteral therapy for heart failure within 12 months prior to baseline evaluation.
4. Patient is 20 years of age or older.
5. Patient is willing and able to comply with the protocol.
6. Patient is able to provide an informed consent to be part of the study.
Key exclusion criteria
1. Patients with life expectancy of less than 15 months.
2. Patients enrolled in a concurrent study that may confound the results of the study.
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Ken Okumura |
Organization
Hirosaki University School of Medicine & Hospital
Division name
Cardiology, Respiratory, Medicine and Nephrology
Zip code
Address
53, Honcho, Hirosaki-shi, Aomori 036-8563, Japan
TEL
0172-33-5111
okumura@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Hidaka |
Organization
Medtronic Japan Co., Ltd.
Division name
Post Market Clinical Research Department, Post Market, Clinical Affairs
Zip code
Address
1-2-70 Konan, Minato-ku,Tokyo, 108-0075, Japan
TEL
03-6776-0055
Homepage URL
kazuhiro.hidaka@medtronic.com
Sponsor or person
Institute
Medtronic Japan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 12 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective, non-randomized, multicenter, observational study.
Management information
Registered date
| 2012 | Year | 12 | Month | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011166
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
