UMIN-CTR Clinical Trial

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
Email	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
Email	akagi-s@cc.okayama-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021312