Usefulness of iloprost in the treatment of pulmonary hypertension secondary to congenital cardiopathies with shunt, in patients with Eisenmenger syndrome
| DEC-NET Serial number ES237 | |
| Published online | 27/05/2004 13.20.00 |
| Last updated | 28/03/2006 13.42.12 |
| Other protocol ID number | EISENMENGER/2003 |
| Current trial status | Planned (i.e. not yet recruiting participants) |
| Major Disease (ICD9 class) | CONG HEART ANOMALY NOS |
| Experimental drug | |
| iloprost | |
| Gender | Both |
| Age (range) | > 1 year |
Eligibility criteria | |
| Inclusion criteria | |
| Pulmonary hypertension secondary to congenital heart disease with intracardiac shunt or abnormal persistence of an open ductus arteriosus after birth with Eisenmenger syndrome and class II or more of the NYHA classification. | |
| Exclusion criteria | |
| Unstable cardiac heart failure. Severe arrhythmia. Significant systemic hypotension. Signs of pulmonary edema. Renal or hepatic failure. Unstable angina or miocardial infarction the previous 6 months. Hemorragic risc. Hypersensitivity to iloprost. | |
Trial design/methodology | |
| Phase | 4 |
| Kind of study | Efficacy |
| Design | abierto y no comparativo |
| Purpose of study | |
| To assess the usefulness of inhaled iloprost for the treatment of pulmonary hypertension in patients with Eisenmenger syndrome, and in this case, to find the minimal effective doses in these patients. | |
| Primary outcomes | |
| Improvement of capacity of exercise (distance in 6 minutes walking test) | |
| Secondary outcomes | |
| Lung pressure Left ventricular function Functional class | |
| Principal investigator | |
| Name | Dr. J. Casaldáliga |
| Institution | Hospital Universitari Vall d'Hebron |
| Postal address | 08035 |
| City | Barcelona |
| Country | ES |
| Phone | 34 934272000 |
| Fax | |
| ISRCTN | EudraCT |
