The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans

niversity Hospital Birmingham0 个研究点目标入组 15 人开始时间: 2008年5月9日最近更新: 2019年11月25日

试验速览

暂无简介。

•Age 18 or over with a Fontan circulation and NYHA II or greater symptoms of heart failure.
•The patient has no other significant illness that would preclude them from completing the study.
•Patients must be available to complete follow up.
•Patients must be able to provide informed consent.
•Patients must agree not to become pregnant during the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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) no
•F.1.3.1 Number of subjects for this age range

•Lack of sinus rhythm at enrolment
•Permanent pacemaker in situ
•Inability to complete exercise testing
•Pre-existent liver disease as described in the bosentan SmPC1
•Significant haematogical abnormality or renal dysfunction.
•Current use of any prostanoid, other endothelion receptor antagonist or pulmonary vasodilator therapy, such as PDE V inhibitors i.e. sildenafil or similar.
•Current enrolment in a clinical trial
•Any contraindication according to the bosentan SmPC1

发起方

niversity Hospital Birmingham