POST-OPERATIVE ATRIAL FIBRILLATION MedDRA version: 20.0 Level: LLT Classification code 10016566 Term: Fibrillation atrial System Organ Class: 100000004849
Conditions
Interventions
Trade Name: OMEGAIBSA2 - 1000 MG CAPSULA MOLLE 2X10 CAPSULE
Product Name: OLEVIA
Product Code: ND
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ACIDI OMEGA 3
Current Sponsor code: ND
Concen
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: 35 DAYS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ Safety of experimental drug ¿ Evaluation of reduction of laboratory inflammatory markers (GB, VES,PCR) ¿ 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 ;Timepoint(s) of evaluation of this end point: 35 DAYS | — |
Countries
Italy
Contacts
Public ContactCARDIOCHIRURGIA
FONDAZIONE POLICLINICO GEMELLI
Outcome results
None listed