UMIN-CTR Clinical Trial

Public title

Randomized controlled Study of Adaptive-servo Ventilator in patients
with congestive heart failure: Confirmatory trial of efficacy on cardiac function

Acronym

SAVIOR-C

Scientific Title

Randomized controlled Study of Adaptive-servo Ventilator in patients
with congestive heart failure: Confirmatory trial of efficacy on cardiac function

Scientific Title:Acronym

SAVIOR-C

Region

Japan

Condition

congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aime of this clinical trial is to confirm Adaptive-Servo Ventilator would be effective on cardiac function in patients with congestive heart failure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Left Ventricular Ejection Fraction(LVEF)

Key secondary outcomes

Events,BNP,Clinical composite responce

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

adaptive-servo ventilator

Interventions/Control_2

control

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)The patients with conjestive heart failure under the conventional therapies
(2)The outpatients could be well addapted Adaptive-Servo Ventilator
(3)NYHA score>=2 in Run-in period
(4)LVEF<40% in Run-in period

Key exclusion criteria

(1)The patients that Adaptive-Servo Ventilator would not be effective
(2)The patients should be avoided to apply Adaptive-Servo Ventilator
(3)Dementia or suspected
(4)difficult to get Informed-Concent
(5)under other clinical researches or trials
(6)Investigator could judge to be exclusive

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Shin-ichi Momoura

Organization

Saitama medical center, Jichi Medical University

Division name

First department of integrated medicine

Zip code

Address

1-847 Amanuma-cho, Omiyaku-ku, Saitama, Saitama 330-8503 Japan

TEL

048-647-2111

Email

Name of contact person

1st name
Middle name
Last name	Yukio Tanaka

Organization

Public Health Reseach Foundation

Division name

CSP-LD Secretariat

Zip code

Address

1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo

TEL

03-5287-2633

Homepage URL

Email

tanaka@crsu.org

Institute

Saitama medical center, Jichi Medical University

Institute

Department

Personal name

Organization

Public Health Reseach Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

自治医科大学さいたま医療センター(埼玉県)
日本医科大学千葉北総病院(千葉県)
広島大学病院(広島県)
群馬県立心臓血管センター(群馬県)
国立病院機構大阪医療センター(大阪府)
国立循環器病センター(大阪府)
北海道大学病院(北海道)
東北大学病院(宮城県)
榊原記念病院(東京都)
富山大学附属病院(富山県)
射水市民病院(富山県)
名古屋大学医学部附属病院(愛知県)
三重大学医学部附属病院(三重県)
兵庫医科大学病院(兵庫県)
徳島大学病院(徳島県)
福岡県済生会二日市病院(福岡県)
九州大学大学院(福岡県)
熊本大学医学部附属病院(熊本県)
日本医科大学付属病院(東京都)
慶応義塾大学病院(東京都)
防衛医科大学校病院(埼玉県)
安城更生病院(愛知県)
名古屋医療センター(愛知県)
名古屋掖済会病院(愛知県)
東住吉森本病院(大阪府)
関西ろうさい病院(兵庫県)
姫路循環器病センター(兵庫県)
東広島医療センター(広島県)
三次中央病院(広島県)
産業医科大学病院(福岡県)
琉球大学医学部附属病院(沖縄県)
小倉記念病院(福岡県)
松山赤十字病院(愛媛県)
愛媛県立中央病院(愛媛県)
長野中央病院(長野県)
北野病院(大阪府)
埼玉医科大学国際医療センター(埼玉県)
天理よろづ相談所病院(奈良県)
大阪赤十字病院(大阪府)
順天堂大学病院(東京都)

Date of disclosure of the study information

2011

Year

10

Month

17

Day

URL releasing protocol

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4331142/

Publication of results

Published

URL related to results and publications

https://www.jstage.jst.go.jp/article/circj/79/5/79_CJ-15-0221/_pdf

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

09

Month

16

Day

Date of IRB

Anticipated trial start date

2011

Year

12

Month

01

Day

Last follow-up date

2013

Year

11

Month

30

Day

Date of closure to data entry

2014

Year

05

Month

31

Day

Date trial data considered complete

2014

Year

09

Month

30

Day

Date analysis concluded

2014

Year

11

Month

30

Day

Other related information

Registered date

2011

Year

10

Month

16

Day

Last modified on

2015

Year

10

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007761