First Repair Treatment with Transcatheter Closure followed by Pulmonary Vasodilator Therapy in Patients with Pulmonary Arterial Hypertension associated with Atrial Septal Defect

First Repair Treatment with Transcatheter Closure followed by Pulmonary Vasodilator Therapy in Patients with Pulmonary Arterial Hypertension associated with Atrial Septal Defect - First Repair Treatment in ASD Patients with PAH

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018877

Enrollment

Registered

2015-09-29

Start date

2015-09-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary hypertension associated with atrial septal defect patients between 5 and 10 wood units of pulmonary vascular resistance

Interventions

Period: 1 year Dose: Transcatheter Closure one time Tracleer 125-250mg/day BID Revatio 60mg/day TID

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Pulmonary vascular resistance and pulmonary artery pressure at 12, 24 and 48 weeks after treatment	—

Countries

Japan

Contacts

Public ContactSatoshi Akagi

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

akagi-s@cc.okayama-u.ac.jp086-235-7351

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026