UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	ppcm@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006653