Clinical studies

PAH therapy

Summary

Patients said to be suffering from Eisenmenger’s syndrome have a severe form of pulmonary arterial hypertension (PAH) resulting from a congenital heart defect. They generally have poor exercise tolerance, a reduced quality of life, and a shortened life expectancy. A heart-and-lung transplant is often the only means of treating this chronic illness. There is therefore an urgent need for new drug-based therapies.

The competence network’s study on “Therapy of pulmonary arterial hypertension (PAH) in patients with congenital heart disease” is seeking methods of proving the efficacy of PAH therapy involving oral administration of two compounds: bosentan (Tracleer®) and sildenafil (Revatio®). The aim is to establish treatment guidelines for use throughout Germany for patients with Eisenmenger’s syndrome, postoperative PAH and the Fontan circulation.

This multi-center study is being carried out in partnership with numerous clinics in Germany that provide medical care for patients with congenital heart defects. All results are entered in a central database and evaluated jointly by the members of the network – a more efficient way of obtaining high-quality research findings.

HP 3.1 Sildenafil therapy for pulmonary arterial hypertension (completed)

Multi-center, prospective, randomised study (German Drugs Act (AMG)) on the use of sildenafil in the treatment of pulmonary arterial hypertension (PAH). Patients with Eisenmenger’s syndrome aged 14 and over were eligible for the study. read more …

HP 3.2 Bosentan therapy for pulmonary arterial hypertension (completed)

Prospective, multi-center study on the use of bosentan in the treatment of pulmonary arterial hypertension (PAH). Patients with Eisenmenger’s syndrome aged 14 and over are eligible for the study. The enrolment of patients closed on 31 March 2007. read more …