drugset / Trial / NCT01548950
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
Completed
50 enrolled
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo · collabInstituto do Coracao · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test the hypothesis that treating PAH-CHD patients preoperatively with PAH drugs and keeping them on treatment for six months after surgery reduces the risk of immediate postoperative death and the risk of residual PAH at six months following operation to \<10%.
Timeline
- Start
- 2011-09
- Primary completion
- 2014-01
- Completion
- 2020-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bosentan | Other / unclassified | 15.6 mg | — |
| Subject | Bosentan | Other / unclassified | 62.5 mg | — |
| Subject | Sildenafil | Unknown | 1 mg/kg | — |
| Subject | Sildenafil | Unknown | 4 mg/kg | — |