UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012669 |
|---|---|
| Receipt number | R000014811 |
| Scientific Title | Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management- |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2016/01/31 16:35:06 |
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Basic information
Public title
Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management-
Acronym
Sildenafil for pulmonary arterial hypertension after pediatric cardiac surgery
Scientific Title
Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management-
Scientific Title:Acronym
Sildenafil for pulmonary arterial hypertension after pediatric cardiac surgery
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Pediatrics | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify efficacy and safety of sildenafil in the treatment of pediatric PAH patients after cardiac surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in mean pulmonary arterial pressure after 4 hour administration from baseline
Key secondary outcomes
PAH crisis disappears
Additional medication for PAH
Successful wean from inhaled nitric oxide or other vasodilators
Rebound PAH
Duration of mechanical ventilation
ICU stay
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sildenafil will be administered via a nasogastric tube or orally at a dose of 0.5 mg/kg. If the investigator note there is no effect of sildenafil on any parameters and clinical conditions, a repeat dose of sildenafil (0.5 or 1.0 mg/kg) can be given 4 hours after the initial administration by the investigators judgment. Sildenafil will be gradually weaned off for 5 to 7 days.
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
| 0 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who fulfill all the criteria shown below are eligible for the trial.
Patients with ages of 0 to 2 years at enrollment
Patients who undergo surgery, 0pen heart surgery
Left to Right shunt anomaly as following
Ventricular septal defect(VSD)
Atrial septal defect(ASD)
Atrioventricular septal defect (AVSD)
Patients who are followed up at ICU in Osaka Medical College or affiliated hospitals.
Mean pulmonary arterial (PA) pressure is over 20 mmHg and/or the ratio of mean PA pressure / mean blood pressure is over 0.5.(measured after the surgery at ICU using a catheter put in the PA)
Patients receive a standard management in the setting of the ICU with a specialized physician.
Parents or guardians of the patients understand the significance of this trial with informed consent before surgery.
Key exclusion criteria
Patients with opened chest
Patients with ventricular assist device
Patients with extracorporeal membrane oxygenation
Patients who are judged as inappropriate to include in this study.
Patients with chronic lung disease, retinopathy, or gastrointestinal problems
Patients who are received Nitrates or nitric oxide donors in non-intravenous form (oral, sublingual, buccal, transdermal, inhalation or aerosol) within 48 hours prior to receiving study drug treatment or intravenous forms within 2 hours prior to receiving study drug treatment (sildenafil is known to potentiate the hypotensive effects of nitrates; its concurrent use is contraindicated)
Patients who are received endothelin antagonists(eg, bosentan)
Patients who are received potent cytochrome P450 3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, and protease inhibitors) (Use of aprotinin will be allowed; aprotinin does not inhibit cytochrome P450 enzymes)
Patients who are received ritonavir or nicorandil.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nemoto, Shintaro |
Organization
Osaka Medical College Hospital
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
snemoto@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Nemoto |
Organization
Osaka Medical College
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
snemoto@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Pfizer Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 24 | Day |
Last modified on
| 2016 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014811
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