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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004335 |
Receipt No. | R000005193 |
Scientific Title | Retrospective cohort study on effects of adaptive-servo ventilator in patients with congestive heart failure : Real World Observation Study |
Date of disclosure of the study information | 2010/10/08 |
Last modified on | 2015/10/09 |
Basic information | ||
Public title | Retrospective cohort study on effects of adaptive-servo ventilator in patients with congestive heart failure : Real World Observation Study | |
Acronym | Retrospective cohort study on effects of ASV in patients with congestive heart failure(SAVIOR-R) | |
Scientific Title | Retrospective cohort study on effects of adaptive-servo ventilator in patients with congestive heart failure : Real World Observation Study | |
Scientific Title:Acronym | Retrospective cohort study on effects of ASV in patients with congestive heart failure(SAVIOR-R) | |
Region |
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Condition | ||
Condition | Congestive heart failure | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To discover particulars of the ASV applied patients with congestive heart failure, survey changes in outcomes before and after ASV application. |
Basic objectives2 | Others |
Basic objectives -Others | Age, gender, height, onset of heart failure, basal heart diseases,
complications, medical history, ASV application data, frequency of hospitalization, vital sign, symptom of heart failure, physical findings, biomedical test, plasma level of BNP, echocardiography, Chest-Xray, clinical impression, Holter monitoring, polysomnography |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | frequency of hospitalization, vital sign, symptom of heart failure, physical findings, biomedical test, plasma level of BNP, echocardiography,
Chest-Xray, Holter monitoring, polysomnography |
Key secondary outcomes |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patient with congestive heart failure
firstly applied with ASV in 2009,at the age was over 20 years. |
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Key exclusion criteria | Patient that investigator judge to be exclusive | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saitama medical center,Jichi medical University | ||||||
Division name | First department of integrated medicine | ||||||
Zip code | |||||||
Address | 1-847 Amanuma, Omiya-ku, Saitama, Saitama 330-8503 Japan | ||||||
TEL | 048-647-2111 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Public Health Research Foundation | ||||||
Division name | CSP-LD Secretariat | ||||||
Zip code | |||||||
Address | 1-1-7 Nishiwaseda,Shinjuku-ku,Tokyo | ||||||
TEL | 03-5287-2633 | ||||||
Homepage URL | |||||||
tanaka@crsu.org |
Sponsor | |
Institute | Saitama medical center,Jichi medical University |
Institute | |
Department |
Funding Source | |
Organization | Public Health Research Foundation |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Public Health Research Foundation |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | 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) 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) 慶応義塾大学病院(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) 広島大学病院(広島県) 徳島大学病院(徳島県) 福岡県済生会二日市病院(福岡県) 熊本大学医学部附属病院(熊本県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.ncbi.nlm.nih.gov/pubmed/25103691 |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Age, gender, height, onset of heart failure, basal heart diseases,
complications, medical history, ASV application data, frequency of hospitalization, vital sign, symptom of heart failure, physical findings, biomedical test, plasma level of BNP, echocardiography, Chest-Xray, clinical impression, Holter monitoring, polysomnography |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005193 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |