UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of cardiac function using pressure-volume loops in congenital heart disease
Acronym	Assessment of cardiac function using pressure-volume loops in congenital heart disease
Scientific Title	Assessment of cardiac function using pressure-volume loops in congenital heart disease
Scientific Title:Acronym	Assessment of cardiac function using pressure-volume loops in congenital heart disease
Region	Japan

Condition
Condition	Congenital heart disease
Classification by specialty	Cardiology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze detailed cardiac function in patients with congenital heart disease, especially with single ventricle physiology and systemic right ventricle.
Basic objectives2	Others
Basic objectives -Others	To improve treatment strategy.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Systolic and diastolic cardiac function
Key secondary outcomes	blood pressure, ventricular pressure, cardiac output, circulatory blood volume, oxygen satulations.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Maneuver
Interventions/Control_1	Occlusion of the inferior vena cava, Dobutamine infusion, and atrial pacing.
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who are admitted to Tokyo Womens's Medical University Hospital, and undergo cardiac catheterization. Patients with single ventricle physiology, and systemic right and left ventricle.
Key exclusion criteria	1. Patients with chromosomal disorders. 2. Patients with systemic syndrome. 3. Patients who may not tolerate occlusion of inferior vena cava. 4. Patients who are considered inadequate to undergo this study.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Toshio Middle name Last name Nakanishi
Organization	Tokyo Women's Medical University
Division name	Department of Pediatric Cardiology
Zip code	162-8666
Address	8-1 Kawada-cho Shinjuku-ku Tokyo
TEL	0333538111
Email	ishido.mikiko@twmu.ac.jp

Public contact
Name of contact person	1st name Mikiko Middle name Last name Ishido
Organization	Tokyo Women's Medical University
Division name	Department of Pediatric Cardiology
Zip code	162-8666
Address	8-1 Kawadacho SHinjukuku Tokyo Japan
TEL	0333538111
Homepage URL
Email	ishido.mikiko@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University Department of Pediatric Cardiology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Women's Medical University
Address	8-1 Kawada cho Shinjukuku Tokyo Japan
Tel	0333538111
Email	ishido.mikiko@twmu.ac.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	東京女子医科大学病院　(東京都)

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 01 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	Preinitiation
Date of protocol fixation	2012 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date	2013 Year 01 Month 07 Day
Last follow-up date	2013 Year 01 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 12 Month 02 Day
Last modified on	2020 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011112