UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009457 |
|---|---|
| Receipt number | R000011112 |
| Scientific Title | Assessment of cardiac function using pressure-volume loops in congenital heart disease |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2020/12/08 15:52:10 |
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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
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
ishido.mikiko@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011112
