F373280 is a new therapy based on DHA delivery (pro-drug) developed for the maintenance of sinus rhythm after electrical cardioversion in persistent atrial fibrillation (AF) patients with chronic heart failure. The results of a pharmacological study performed in animals evidenced that DHA reduces the duration of Atrial Fibrillation (AF) induced by burst pacing. MedDRA version: 14.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: panthenyl ester of DHA
Product Code: F373280
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: panthenyl ester of DHA
Current Sponsor code: F373280
Other descriptive name: DOCOSAHE
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Demographic Characteristics and Other Baseline Characteristics: 1.Men or women aged more than 18 years (inclusive), 2.Patients with persistent AF between 7 days and 6 months duration for whom electrical cardioversion is warranted. 3.History of first documented persistent AF less than 1 year 4.History of ischemic or non ischemic heart failure 5.NYHA class I or II chronic heart failure at selection and at inclusion 6.Reduced left ventricular ejection fraction between 30 and 45% inclusive (using the two-dimensional echocardiography biplane Simpson?s rule) ) at selection and at inclusion 7.On appropriate, stable medical treatments for heart failure, including a diuretic and/or angiotensin-converting enzyme, and/or angiotensin-receptor blocker and/or mineralocorticoid receptor (MR) antagonists, and/or betablockers 8.Left atrial area ? 40 cm² ) at selection and at inclusion 9.Patients treated or having to be treated by anti-vitamin K 10. For female patient of child-bearing potential: -use of an effective method of contraception (hormonal contraception or intra-uterine device) assessed by the investigator, for at least 2 months before the selection in the study, and agreement to go on using it during the whole duration of the study and up to 1 month after the last dose of the study treatment -documented as surgically sterilized 11.For female patient of child-bearing potential: negative urine pregnancy test at inclusion Ethical /legal considerations: 12.Having signed his/her written informed consent, 13.Affiliated to a social security system, or is beneficiary (if applicable in the national regulation) 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 122 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Criteria related to pathologies: 1.History of first documented episode of persistent AF more than 1 year 2.More than two successful cardioversions (electrical or pharmacological) in the last 6 months 3.Secondary Atrial Fibrillation due to alcohol or severe valvular heart disease (grade III to IV) 4.NYHA class III or IV heart failure at selection or at inclusion 5.Thyroid disease uncontrolled by treatment: TSH ± T4L ± T3L to be check in case of treatment for thyroid disease 6.Myocardial infarction or unstable angina or presence of unstable ischemic coronaropathy assessed by coronarography or cardiac stress test (Echo stress, exercice stress test, nuclear or MR perfusion evaluation methods) within 6 months before selection 7.Severe chronic kidney disease (creatinine 25 mg/L or estimated glomerular filtration rate 5.5 mEq/L or K < 3.5 mEq/L) at selection 10.Cardiac surgery within 3 months before selection or planned during the study duration Criteria related to treatments: 11.Previously ineffective pharmacological or electrical cardioversion 12.Concomitant treatment with any anti-arrhythmic drug (within 7 days prior to selection), except stable dose of digoxin, betablockers, calcium-blockers 13.Previous treatment with oral amiodarone within 12 months prior to inclusion 14.Previous treatment with intravenous amiodarone within 6 months prior to inclusion 15.Patient requiring a cardiac resynchronization therapy (CRT) or having undergone CRT implantation within the last 6 months 16.Treatment with any Polyunsaturated Fatty Acid (PUFA) within the last 3 months 17.Dietary supplement with ?3 or ?6 according to investigator?s judgementgement 18.Having undergone any form of ablation therapy for AF 19.Patient treated with other anticoagulant treatment than antivitamin K: thrombin inhibitor such as Dabigatran or treated with antiaggregant P2Y12 inhibitors such as Clopidogrel or Prasugrel Other criteria: 20.Patient liable not to comply with protocol instructions and/or with treatment, in the investigator?s opinion 21.Patient having taken part in a clinical trial in the preceding 2 months or taking part in a trial at the time of selection 22.Patient linguistically or mentally unable to understand the nature, objectives and possible consequences of the trial, or refusing to patient himself/herself to its constraints 23.Patient family member or work associate (secretary, nurse, technician,..) of the Investigator 24.Patient having forfeited his / her freedom by administrative or legal award or being under guardianship 25. Breastfeeding mother
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: Efficacy of F373280 on the maintenance of sinus rhythm after direct electrical cardioversion in patients with persistent atrial fibrillation and chronic heart failure;Secondary Objective: Secondary: - Efficacy of F373280 on the efficiency of direct electrical cardioversion - Effect of F373280 on echocardiographic parameters - Safety and tolerability of F373280;Primary end point(s): efficacy;Timepoint(s) of evaluation of this end point: Time to first Atrial Fibrillation recurrence defined by the first episode of Atrial Fibrillation lasting for at least 10 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): safety;Timepoint(s) of evaluation of this end point: Adverse events Vital signs Physical examination Standard 12-lead ECG Haematology Biochemistry Coagulation parameters | — |
Countries
Czech Republic, Hungary, Italy, Spain
Contacts
Public ContactGUIRAUD Marlène
INSTITUT DE RECHERCHE PIERRE FABRE - Centre de R&D Pierre Fabre
Outcome results
None listed