UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of tadarafil for persistant pulmonary hypertension early after congenital heart surgery in children
Title of the study (Brief title)	Effect of tadarafil for PH early after CHD surgery
Region	Japan

Condition
Condition	congenital heart disease associated with pulmonary hypertension after open heart surgery
Classification by specialty	Pediatrics Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to validate efficacy and safety of tadarafil for persistent pulmonary hypertension early after open heart surgery in children
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood pressure, heart rate, pulmonary artery pressure, SpO2, blood concentration of tadarafil (before administration, 2,4,6,8,12,16,20,24 hours after administration)
Key secondary outcomes	presence or absence of adverse event of tadarafil

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	For intubated children with pulmonary hypertension after open heart surgery,0.5mg/kg of tadarafil will be administered orally, and same dose of tadarafil will be added 12 hours after initial administration.
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	16 years-old >
Gender	Male and Female
Key inclusion criteria	children younger than 16 years old with persistent pulmonary hypertension early after open heart surgery
Key exclusion criteria	case who is administered other drugs for pulmonary hypertension
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroshi Tamai
Organization	Osaka Medical College
Division name	Department of Pediatrics
Address	2-7, Daigaku-machi, Takatsuki, Osaka
TEL	072-683-1221
Email	ped001@poh.osaka-med.ac.jp

Public contact
Name of contact person	Hiroshi Katayama
Organization	Osaka Medical College
Division name	Department of Pediatrics
Address	2-7, Daigaku-machi, Takatsuki, Osaka
TEL	072-683-1221
Homepage URL
Email	ped100@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Department of Pediatrics
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 03 Day
Anticipated trial start date	2014 Year 03 Month 03 Day
Last follow-up date	2017 Year 03 Month 03 Day
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

Management information
Registered date	2014 Year 03 Month 03 Day
Last modified on	2017 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015536