Olevia for the prevention of atrial fibrillation post heart valve-surgery. - ND

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 152 人开始时间: 2020年10月6日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•Informed consent signed before starting any procedure provided by the study;
•age = 18 years;
•candidates for heart valve surgery;
•Sinus rhytm on ECG performed at pre-hospedalization time (with or not history of atrial fibrillation).
•Sexual abstinence for two months for male patients.
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

•Treatment ongoing with Olevia (hypertriglyceridemia, post-ischemic heart attack) at the time of enrollment;
•controindications to Olevia and excipiens;
•indication to combined heart valve surgery and coronary artery bypass surgery
•impaired liver function (transaminase 1,5 times the upper reference limit );
•impaired renal function (serum creatinine =2.5 mg/dl);
•pregnancy, breast-feeding, women in childbearing age;
•blood dyscrasias (anemias with HB <10 g/dl, myelodysplastic syndromes,myeloproliferative syndromes) thrombocytopenia.
•gastrointestinal inflammatory diseases;
•autoimmune diseases;
•hypersensivity to the active substance or to soya lecithin or to any of the excipients;
•patients unable to give informed consent.

发起方

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE