UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Echocardiographic clinical stratification of pregnant women with dilated cardiomyopathy
Title of the study (Brief title)	Echocardiographic clinical stratification of pregnant women with dilated cardiomyopathy
Region	Japan

Condition
Condition	Pregnancy complicated with dilated cardiomyopathy
Classification by specialty	Cardiology Obsterics and gynecology Anesthesiology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate the echocardiographic clinical stratification to detect pregnant women who require intervention in delivery. High risk group satisfies at least one of following criteria before 34 weeks of pregnancy. 1. Left ventricular end-diastolic diameter /Height is more than 37mm/m 2. Left ventricular end-systolic diameter/Height is more than 26mm/m 3. Ejection fraction is 35% or less 4. Relative wall thickness is less than 0.24 Relative wall thickness=2(Posterior wall thickness)/Left ventricular end-diastolic diameter
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	To compare the proportion of pregnant women who require intervention. We use chi-square test for primary outcome. The criteria of intervention 1. Emergency cesarean section 2. Artificial preterm delivery for cardiac complications 3. Forced delivery for fetal distress syndrome
Key secondary outcomes	Kaplan-Meier Curve of event free 8-year survival after delivery. The events satisfy at least one of following criteria 1. Death 2. Heart failure 3. Stroke 4. Cardiac surgery 5. Arrhythmia

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	Pregnant women with dilated cardiomyopathy
Key exclusion criteria	Muscular dystrophy Congental cardiac disease Peripartum cardiomyopathy Dilated phase of hypertrophic cardiomyopathy
Target sample size	26

Research contact person
Name of lead principal investigator	Makoto Sasaki
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Anesthesiology
Address	5-7-1 Fujishirodai, Suita, Oosaka 565-8565, Japan
TEL	+81-6-6833-5004
Email	Sasaki-receives@ncvc.go.jp

Public contact
Name of contact person	Makoto Sasaki
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Anesthesiology
Address	5-7-1 Fujishirodai, Suita, Oosaka 565-8565, Japan
TEL	+81-6-6833-5004
Homepage URL
Email	Sasaki-receives@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立研究開発法人国立循環器病研究センター

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 06 Day
Anticipated trial start date	2017 Year 11 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Retrospective cohort Study Pregnant women with dilated cardiomyopathy in National Cerebral and Cardiovascular Center since 1984.

Management information
Registered date	2017 Year 11 Month 06 Day
Last modified on	2017 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034081