UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020345 |
|---|---|
| Receipt number | R000023475 |
| Scientific Title | The study of early diagnostic methods for pregnancy associated cardiomyopathy |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2021/07/02 11:22:21 |
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Basic information
Public title
The study of early diagnostic methods for pregnancy associated cardiomyopathy
Acronym
PREACHER 2
Scientific Title
The study of early diagnostic methods for pregnancy associated cardiomyopathy
Scientific Title:Acronym
PREACHER 2
Region
| Japan |
Condition
Condition
Peripartum Cardiomyopathy and Pregnancy Associated Cardiomyopathy
Classification by specialty
| Cardiology | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Peripartum cardiomyopathy and pregnancy associated cardiomyopathy are life-threatening cardiomyopathy. More than a half of patients have risk factors (complication of pregnancy associated hypertension, multiple births, and tocolytic therapy). In this study, we investigate pregnant women with risk factors for peripartum cardiomyopathy by BNP and/or echocardiography, and to develop the early diagnostic methods.
Basic objectives2
Others
Basic objectives -Others
Clinical research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of peripartum cardiomyopathy among the study participants
Key secondary outcomes
The comparison of BNP levels between patients with and without peripartum cardiomyopathy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Peripartum patients with risk factors of peripartum cardiomyopathy; pregnancy associated hypertension, multiple conseption, family history of dilated cardiomyopathy, usage of tocolitic agents
Key exclusion criteria
Patients without informed consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Yoshimatsu |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Perinatology and Gynecology
Zip code
5648565
Address
6-1 KishibeShinmachi, Suita, Osaka Japan
TEL
06-6170-1070
ppcm@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Chizuko |
| Middle name | |
| Last name | Kamiya |
Organization
National Cerebral and Cardiovascular Center
Division name
The clinical investigation group for peripartum cardiomyopathy
Zip code
5648565
Address
6-1 KishibeShinmachi, Suita, Osaka Japan
TEL
06-6170-1070
Homepage URL
ppcm@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
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
National Cerebral and Cardiovascular Center
Address
6-1 KishibeShinmachi, Suita, Osaka Japan
Tel
06-6170-1070
chiz@ncvc.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 25 | 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
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow-up data:
symptoms of heart failure
BNP
echocardiography
Management information
Registered date
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023475
