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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006705
Receipt No. R000007923
Scientific Title Short Term Effects of Waon Therapy on Patients with Chronic Heart Failure: Prospective Multicenter Clinical Trial by Waon Equipment
Date of disclosure of the study information 2011/11/14
Last modified on 2016/10/19

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Basic information
Public title Short Term Effects of Waon Therapy on Patients with Chronic Heart Failure: Prospective Multicenter Clinical Trial by Waon Equipment
Acronym Short Term Effects of Waon Therapy on Heart Failure
Scientific Title Short Term Effects of Waon Therapy on Patients with Chronic Heart Failure: Prospective Multicenter Clinical Trial by Waon Equipment
Scientific Title:Acronym Short Term Effects of Waon Therapy on Heart Failure
Region
Japan

Condition
Condition Chronic Heart Failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects and safety of Waon therapy for 2 weeks in CHF patients by prospective multicenter trial using Waon equipment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of plasma BNP levels 2 weeks after the start of study.
Key secondary outcomes NYHA functional class, 6 min walk distance, cardiothoracic ratio of chest Xp, ejection fraction of echocardiogram, heart rate, arrhythmia, bundle branch block, incidence of adverse event

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Conventional therapy of heart failure and Waon therapy for 2 weeks (10 times)
Interventions/Control_2 Conventional therapy of heart failure for 2 weeks
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with CHF such as dilated cardiomyopathy and ischemic
2) Patients who agree the informed consent
3) Patients who can move to Waon equipment by their selves or by wheel-chair from their room
Key exclusion criteria 1) 1) Untreated HF patients
2) Severe aortic stenosis which pressure gradient is 50 mmHg or more.
3) Hypertrophic obstructive cardiomyopathy with severe LV and out-flow obstruction (the pressure gradient is 50 mmHg or more).
4) Patients with active infection or fever with 37 cent-degrees or more.
5) Patients who had myocardial infarction or stroke within 6 months.
6) Cancer, or less than 5 years from healing cancer.
7) Patients treated with hemodialysis
8) Patients whose body weight is 135 kg or more.
9) Patients who are judged as inappropriate subjects by physician.
Target sample size 152

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Ohishi
Organization Kagoshima University
Division name Cardiovascular Medicine and Hypertension
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima City
TEL +81-99-275-5316
Email ohishi@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Miyata
Organization Kagoshima University
Division name Cardiovascular Medicine and Hypertension
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima City
TEL 099-275-5318
Homepage URL
Email miyatam@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute Cardiovascular Medicine and Hypertension
Institute
Department

Funding Source
Organization Study Group of Waon Therapy
Organization
Division
Category of Funding Organization Other
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 鹿児島大学病院(鹿児島県)/ Kagoshima University Medical and Dental Hospital
東京大学医学部附属病院(東京都)/ The University of Tokyo Hospital
国立大学法人富山大学附属病院(富山県)/Toyama University Hospital
福岡大学病院(福岡県)/ Fukuoka University Hospital
兵庫医科大学病院(兵庫県)/ The Hospital of Hyogo College of Medicine
東邦大学医療センター佐倉病院(千葉県)/Toho University Medical Center Sakura Hospital
東京都健康長寿医療センター(東京都)/ Tokyo Metropolitan Geriatric Hospital
獨協医科大学病院(栃木県)/Dokkyo Medical University Hospital
岡山大学病院(岡山県)/Okayama University Hospital
埼玉医科大学国際医療センター(埼玉県)/ Saitama Medical University International Medical Center
京都府立医科大学附属病院(京都府)/ University Hospital, Kyoto Prefectural of Medicine
順天堂大学医学部附属順天堂医院(東京都)/ Juntendo University Hospital
昭和大学病院(東京都)/ Showa University Hospital
福島県立医科大学附属病院(福島県)/ Fukushima Medical University Hospital
独立行政法人国立病院機構函館病院(北海道)/ Hakodate National Hospital
東京女子医科大学病院(東京都)/ Tokyo Women's Medical University Hospital
北里研究所病院(東京都)/ Kitasato Institute Hospital
公益財団法人日本心臓血圧研究振興会附属 榊原記念病院(東京都)/Sakakibara Memorial Hospital in Affiliation with the Japan Research Promotion Society for Cardiovascular Diseases

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/80/4/80_CJ-16-0051/_article
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
2011 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2014 Year 05 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
2011 Year 11 Month 11 Day
Last modified on
2016 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007923

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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