UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018877 |
|---|---|
| Receipt number | R000021312 |
| Scientific Title | First Repair Treatment with Transcatheter Closure followed by Pulmonary Vasodilator Therapy in Patients with Pulmonary Arterial Hypertension associated with Atrial Septal Defect |
| Date of disclosure of the study information | 2015/09/29 |
| Last modified on | 2019/09/05 13:20:45 |
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Basic information
Public title
First Repair Treatment with Transcatheter Closure followed by Pulmonary Vasodilator Therapy in Patients with Pulmonary Arterial Hypertension associated with Atrial Septal Defect
Acronym
First Repair Treatment in ASD Patients with PAH
Scientific Title
First Repair Treatment with Transcatheter Closure followed by Pulmonary Vasodilator Therapy in Patients with Pulmonary Arterial Hypertension associated with Atrial Septal Defect
Scientific Title:Acronym
First Repair Treatment in ASD Patients with PAH
Region
| Japan |
Condition
Condition
pulmonary hypertension associated with atrial septal defect patients between 5 and 10 wood units of pulmonary vascular resistance
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of atrial septal defect transcatheter closure followed by pulmonary vasodilator therapy in pulmonary hypertension patients between 5 and 10 wood units of pulmonary vascular resistance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary vascular resistance and pulmonary artery pressure at 12, 24 and 48 weeks after treatment
Key secondary outcomes
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 | Maneuver |
Interventions/Control_1
Period: 1 year
Dose: Transcatheter Closure one time
Tracleer 125-250mg/day BID
Revatio 60mg/day TID
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A.Patients with pulmonary hypertensin associated with ASD.
1. mean pulmonary artery pressure more than 25mmHg and pulmonary vascular resistance more than 5 wood units, under 10 wood units.
2. Reduction of pulmonary vascular resistance by 100% oxygen test.
B.Patients with ASD
1. Defect size of ASD under 38 mm
Key exclusion criteria
A.Co-exist of other cause PH (collagen, pulmonary diseases, pulmonary embolism, left heart disease)
B.Co-exist of other congenital heart diseases except for ASD
C.Treatment of PAH-specific drugs(prostacyclin, endothelin receptor antagonist, PDE5 inhibitor, soluble guanylate cyclase stimulator)
D.Eisenmenger syndorome(Qp/Qs<1)
E.Bleeding or risk of bleeding
F.Atrial fibliration
G.Pregnat or possible pregnant woman and lactating woman
H.moderate renal dysfunction (Cre more than 1.5mg/dl)
I.moderate liver dysfunction (AST and ALT more than 2 times normal limit)
J.Hypotension (sBP less than 90mmHg)
K.Low cardiac output (cardiac index under 2.2l/min/m2)
L.LV ejection fraction under 50%
M.hypersensitivity of drugs
N.inadequate patients with whom physician evaluate
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Ito |
| Middle name | |
| Last name | Ito |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
700-8558
Address
2-5-1, shikata-cho kitaku, okayama city
TEL
086-235-7351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Akagi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
700-8558
Address
2-5-1, shikata-cho kitaku, okayama city
TEL
086-235-7351
Homepage URL
akagi-s@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
okayama university hospital ethics committee
Address
2-5-1,kita-ku, shikata-cho, okayama
Tel
086-235-6503
mae6605@adm.okayama-u.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 29 | 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
0
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
| 2015 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021312
