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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003351
Receipt No. R000004068
Scientific Title Validity of OptiVol alert MOMOTARO study (MOnitoring and Management of OpTiVol Alert to Reduce heart failure admissiOn)
Date of disclosure of the study information 2010/04/01
Last modified on 2010/08/06

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Basic information
Public title Validity of OptiVol alert
MOMOTARO study
(MOnitoring and Management of OpTiVol Alert to Reduce heart failure admissiOn)
Acronym MOMOTARO study
Scientific Title Validity of OptiVol alert
MOMOTARO study
(MOnitoring and Management of OpTiVol Alert to Reduce heart failure admissiOn)
Scientific Title:Acronym MOMOTARO study
Region
Japan

Condition
Condition Patient who has organic heart disease with ICD or CRTD.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison the data in OptiVol alert to the data in control.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of BNP and E/e' in OptiVol alert to that in control
Key secondary outcomes Comparison of other data in OptiVol alert to that in control

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 Patient who has organic heart disease and requiring ICD or CRTD.
Patient received ICD or CRTD.
Key exclusion criteria 1) Patient under 20 years old.
2) Patient with moderate or severe chronic obstructive lung disease (forced expiratory volume < 1.0 L/s).
3) Patient who is received heart transplantation or is supposed to receive heart transplantation.
4) Patient with primary pulmonary hypertension.
5) Patient with dialysis.
6) Patient under one year of life expectancy.
7) Patient with pregnancy or possible pregnancy.
8) Patient in whom doctor think inadequate.
9) Patient with heart failure in enrollment.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ito
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical
Division name Department of Cardiovascular Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7351
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Nishii
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical
Division name Department of Cardiovascular Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7351
Homepage URL
Email nnishii@md.okayama-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 心臓病センター榊原病院(岡山)、倉敷中央病院(岡山)、国立病院機構岡山医療センター(岡山)、岡山ハートクリニック(岡山)、福山市民病院(広島)、福山循環器病院(広島)、香川県立中央病院(香川)、津山中央病院(岡山)、川崎大学病院(岡山)、鳥取市立市民病院(鳥取)、国立病院機構岩国医療センター(山口)、愛媛県立中央病院(愛媛)、今治済生会病院(愛媛)、高知医療センター(高知)、幡多けんみん病院(高知)

Other administrative information
Date of disclosure of the study information
2010 Year 04 Month 01 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
2010 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information undetermined

Management information
Registered date
2010 Year 03 Month 18 Day
Last modified on
2010 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004068

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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