Evaluation of tolerability and efficacy of the combination Sildenafil/Bosentan in patients with severe pulmonary hypertension.

CASA DI CURA PRIVATA S.RAFFAELE - PISANA0 个研究点目标入组 60 人开始时间: 2011年12月6日最近更新: 2012年3月19日

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•Inclusion criteria 1) Patients with idiopathic or familial pulmonary arterial hypertension (PAH) 2) Patients with distal Chronic Thromboembolic Pulmonary Hypertension 3) PAH associated to connective tissue disease, anorexigen, congenital heart disease. 4) Age > 18 years 5) Mean pulmonary pressure > 25 mmHg, mean pulmonary capillary ''wedge'' pressure <15 mm Hg at right catheterization evaluation 6) No vasodilating response to inhaled nitric oxide, or ''vasoreactive'' patients in chronic calcium channel blockers 7) WHO functional class 2-3
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1) Significant reduction in pulmonary function test (FVC, FEV1 < 70 % normal predicted value) 2) Treatment with other drug for PAH (endothelin receptor antagonist, prostanoids, PDE-5 inhibitors 3) Previous combination therapy with current drugs 4) Systemic hypotension (systolic blood pressure < 90 mmHg) 5) Chronic liver disease (Child-Pugh class B o C) or transaminases increased > 3 fold upper normal limits 6) Pshyschiatric disease or other condition that will be an impediment to the protocol 7) Pregnancy or lactation 8) Known hypersensitivity to bosentan or sildenafil 9) Treatment with other drugs that could have significant interaction with bosentan or sildenafil: calcineurine inhibitors (ciclosporine tacrolimus…), antimycotics (fluconazole, chetoconazole…), amiodarone, antiretroviral drug, glibencamide, nitrates, alfa-blockers.

发起方

CASA DI CURA PRIVATA S.RAFFAELE - PISANA