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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004190
Receipt No. R000005034
Scientific Title A multi-institutional study on mobidity,mortality and medical treatment of adult patients with Eisenmenger syndrome
Date of disclosure of the study information 2010/09/10
Last modified on 2018/09/16

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Basic information
Public title A multi-institutional study on mobidity,mortality and medical treatment of adult patients with Eisenmenger syndrome
Acronym A multi-institutional study on mortality of patients with Eisenmenger syndrome
Scientific Title A multi-institutional study on mobidity,mortality and medical treatment of adult patients with Eisenmenger syndrome
Scientific Title:Acronym A multi-institutional study on mortality of patients with Eisenmenger syndrome
Region
Japan Asia(except Japan)

Condition
Condition Eisenmenger syndrome
Classification by specialty
Cardiology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify morbidity, mortality and status of medical treatment, to assess effects of medical treatment for morbidity and mortality
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes survival, six minute's walk distance
Key secondary outcomes cardiac dysfunction,
pulmonary thromboembolism

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria definition of Eisenmenger syndrome
reversed or bidirectional shunts through a large defect between the systemic and pulmonary circulation at ventricular, atrial or aorto-pulmonary levels
Key exclusion criteria Pulmonary atresia with ventricular septal defect
a history of any cardiac surgery including palliative surgery
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisanori Sakazaki
Organization Hyogo prefectural Amagasaki General Medical center
Division name pediatric cardiology
Zip code
Address 2-17-77 Higashinaniwacho, Amagasaki city, Hyogo, Japan
TEL 06-6480-7000
Email sakazaki@pb4.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisanori Sakazaki
Organization Hyogo prefectural Amagasaki General medical center
Division name pediatric cardiology
Zip code
Address 2-17-77 Higashinaniwacho, Amagasaki city,hyogo, Japan
TEL 06-6480-7000
Homepage URL https://esmcs.net/
Email sakazaki@pb4.so-net.ne.jp

Sponsor
Institute Research committee of Japanese Society of Pediatric Cardiology and Cardiac Surgery
Institute
Department

Funding Source
Organization Japanese Society of Pediatric Cardiology and Cardiac Surgery
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 兵庫県立尼崎総合医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
88 patients were enrolled(median age, 34years 69% female). During a median follow up of3.3 years, 24 patients experienced Clinical Worsening including death in eight and lung transplant in one. The 5 years rate of freedom from CW was 67% and the 5 years of freedom from death and transplant was 86%. The mean value of BNP in the patients with CW was significantly higher than without CW(170pg/dl vs 62, p=0.002). Those with CW presented worse WHO function class at enrollment, with 41% WHO function class3 or greater, as compared with 18% in those without CW(P=0.02). 60 patients (69%) were treated with at least one DTT,there were improvement of SPO2 or WHOFC in 7 patients, no change in10, transplant list in 2.
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 Open public recruiting
Date of protocol fixation
2013 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information valuables:Down syndrome, complex anatomy, a history of syncope, a history of ventricular arrhythmia, disease targetting therapy, Warfarin, Home oxygen therapy, phlebotomy, echocardiographic parameter, cardiothoracic ratio, electrocardiographic parameter
prospective study
case control study

Management information
Registered date
2010 Year 09 Month 10 Day
Last modified on
2018 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005034

Research Plan
Registered date File name
2018/09/16 臨床研究計画書.docx

Research case data specifications
Registered date File name
2018/09/16 ESMCSデータ記入用紙.pdf

Research case data
Registered date File name
2018/09/16 抄録ES.docx


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