UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006705
Receipt number 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 13:30:38

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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 or person

Institute

Cardiovascular Medicine and Hypertension

Institute

Department

Personal name



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

Value
https://center6.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