UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005629 |
|---|---|
| Receipt number | R000006653 |
| Scientific Title | Pregnancy Associated Cardiomyopathy and Hypertension-Essential Research |
| Date of disclosure of the study information | 2011/05/26 |
| Last modified on | 2020/12/28 11:05:11 |
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Basic information
Public title
Pregnancy Associated Cardiomyopathy and Hypertension-Essential Research
Acronym
PREACHER
Scientific Title
Pregnancy Associated Cardiomyopathy and Hypertension-Essential Research
Scientific Title:Acronym
PREACHER
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
Although peripartum cardiomyopathy and pregnancy associated cardiomyopathy are life-threatening cardiomyopathy, little was known about the characteristics of this disease in Japan. We performed a nationwide questionnaire survey of PPCM cases in 2007 and 2008 and incidence (1/20,000 deliveries), risk factors (age, complication of hypertension, multiple births, and tocolytic therapy), and several clinical problems became clear. In this prospective study, we investigate further about detail medical histories, risk factors (especialy hypertension), long term outcomes, treatment, and laboratory parameters.
Basic objectives2
Others
Basic objectives -Others
Clinical epidemiology research
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
-One year follow-up
(at diagnosis, 1-2 weeks later, 3 months later, 6 monthes later, 1 year later)
-medical history
-in cases with hypertension
details of clinical course of pregnancy
-vitals
-ECG
-UCG
-laboratory data
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Development of heart failure during pregnancy or within the first 5 postpartum months
(2) No determinable etiology for cardiac failure
(3) No history of heart disease prior to pregnancy
(4) Reduced left ventricular contraction based on a left ventricular ejection fraction (LVEF) <50%
Key exclusion criteria
not applicable above
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Ikeda |
Organization
Mie University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
5140001
Address
2-174 Edobashi, Tsu, MIE
TEL
059-232-1111
t-ikeda@clin.medic.mie-u.ac.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
5658564
Address
6-1kishibeshinmachi, 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
Japan
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
国立循環器病研究センター（大阪府）、症例登録施設
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 26 | 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
| 2010 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2011 | Year | 05 | Month | 23 | Day |
Last modified on
| 2020 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006653
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
