UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012714 |
|---|---|
| Receipt number | R000014348 |
| Scientific Title | The multicenter study on heart failure treatment with intrathoracic impedance: MOMOTARO II study (MOnitoring and Management of OpTiVol Alert to Reduce heart failure hOspitalization) |
| Date of disclosure of the study information | 2013/12/27 |
| Last modified on | 2021/01/28 13:44:36 |
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Basic information
Public title
The multicenter study on heart failure treatment with intrathoracic impedance: MOMOTARO II study
(MOnitoring and Management of OpTiVol Alert to Reduce heart failure hOspitalization)
Acronym
MOMOTARO II study
Scientific Title
The multicenter study on heart failure treatment with intrathoracic impedance: MOMOTARO II study
(MOnitoring and Management of OpTiVol Alert to Reduce heart failure hOspitalization)
Scientific Title:Acronym
MOMOTARO II study
Region
| Japan |
Condition
Condition
Patient who has organic heart disease and requiring ICD or CRTD.
Patient received ICD or CRTD.
1) Patient with less than 40% of LVEF
2) Patient with past history of heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine what therapy is effective in patients with decreased intrathoracic impedance in OptiVol alert.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of intrathoracic impedance and BNP in OptiVol alert to that after 1 week
Key secondary outcomes
Comparison of other parameters in OptiVol alert to that after 1 week
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Furosemide 10mg/day oral
Interventions/Control_2
Nitroglycerin 10mg/day patch
Interventions/Control_3
Education of life style
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.
1) Patient less than 40% of LVEF
2) Patient with past history of heart failure
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 renal failure of stage IV or V. (GFR <15 mL/min/1.73 m^2)
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.
10) Severe heart failure patients with necessity of hospitalization
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Miyoshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
Homepage URL
http://study.momotaro-med.com/momotaro-study/
akihito344jp@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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
Center of Innovative Clinical Medicine
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city
Tel
086-235-6503
mae6605@adm.okayama-u.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
岡山大学病院（岡山県）、倉敷中央病院(岡山県)、国立病院機構岡山医療センター(岡山県)、福山市民病院(広島県)、福山循環器病院(広島県)、香川県立中央病院(香川県)、津山中央病院(岡山県)、岩国医療センター(山口県)、済生会今治病院(愛媛県)、愛媛県立中央病院(愛媛県)、高知医療センター(高知県)、高松赤十字病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circj/84/3/84_CJ-19-0986/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/84/3/84_CJ-19-0986/_article
Number of participants that the trial has enrolled
156
Results
Our ITI algorithm could properly find slight fluid retention without apparent symptom. Early intervention, such as lifestyle modification, diuretics or nitrates, for asymptomatic HF patients diagnosed by our ITI algorithm could improve the condition of patients.
Results date posted
| 2021 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion criteria were as follows: <40% of left ventricular ejection fraction (LVEF) or a history of HF hospitalization within 1 year.
Participant flow
Patients were followed by remote monitoring. Patients come to the hospital based on a heart failure alert, and if signs of heart failure are present, they are assigned to the diuretic group, nitrate group, or lifestyle modification group, and are re-examined after one week.
Adverse events
None
Outcome measures
BNP, intrathoracic impedance
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | 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
| 2013 | Year | 12 | Month | 27 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014348
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