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- Conditions
- POST-OPERATIVE ATRIAL FIBRILLATIONMedDRA version: 20.0Level: LLTClassification code 10016566Term: Fibrillation atrialSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-002956-25-IT
- Lead Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 152
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the antiarrhythmic effect of Olevia as add-on to standard therapy in patients undergoing heart valve surgery.;Secondary Objective: ND;Primary end point(s): Reduction in the incidence of atrial fibrillation in patients undergone surgical operation for valve disease and treated with Olevia 1000 mg per os three times daily in addition to standard therapy for 30 days before cardiac surgery. <br><br>;Timepoint(s) of evaluation of this end point: 35 DAYS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ¿Safety of experimental drug<br>¿Evaluation of reduction of laboratory inflammatory markers (GB, VES,PCR) <br>¿Evaluation of the effect of Olevia in post-operative atrial and ventricular remodeling in patients that at the time of randomization have an echocardiogram performed until six months before the date of signing informed consent<br>;Timepoint(s) of evaluation of this end point: 35 DAYS