Efficacy and safety international, multicentric, randomised,double- blind,placebo controlled study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.
- Conditions
- Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]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: 17.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders
- Registration Number
- EUCTR2012-003487-48-HU
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 135
Demographic Characteristics and Other Baseline Characteristics:
1.Men or women aged more than 18 years (inclusive)
2.Patients with current episode of persistent AF between 7 days and 6
months duration for whom electrical cardioversion is warranted
3.Previous history of first documented episode of persistent AF.
4.Previous history of ischemic or non ischemic heart failure
5.NYHA class I or II chronic heart failure at selection and at inclusion
6.Left ventricular systolic dysfunction defined at selection and at
inclusion by a reduced left ventricular ejection fraction (LVEF) = 30%
and = 45% or for patients with a LVEF > 45%:
•an increased left ventricular end-diastolic size (diameter = 60 mm
and/or > 32 mm/m² and/or volume > 97 ml/m²)
•and/or an increased left ventricular end-systolic size
(diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²)
•and/or a reduced left ventricular outflow tract velocity time integral <
15 cm
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 vitamin K antagonist
10.For female patient of child-bearing potential:
•In all the countries except Italy:
-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
•In Italy only:
-Absolute abstention from sexual intercourse during the whole duration
of the study and for a month after the end of the study or
-Use of double barrier contraception method (use of effective medical
contraception method) from at least 2 months before the start of the
study to the entire duration of the study and for a month after the end of
the study or
-Documented as surgically sterilized
11.For female patient of child-bearing potential: negative urine
pregnancy test at inclusion
12.For male with a child-bearing potential partner (In Italy only):
-Absolute abstention from sexual intercourse during the whole duration
of the study and for 3 months after the end of the study or
-Use of double barrier contraception method (use of condom for male
and effective contraception method for the partner) from the entire
duration of the study to 3 months after the end of the study.
Ethical / legal considerations:
13.Having signed his/her written informed consent,
14.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 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
Non-Inclusion Criteria:
Criteria related to pathologies:
1.No previous history of first documented episode of persistent AF
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
checked 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, exercise 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 < 30 ml/min) at selection
8.Bradycardia (HR = 50 bpm)
9.Hyperkalemia or hypokalemia (according to the standards of local
laboratories) 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 ranolazine or any antiarrhythmic drug
(within 7 days prior to selection), except amiodarone, dronedarone and
stable dose of digoxin, betablockers, calcium-blockers
13.Concomitant treatment with oral amiodarone or dronedarone from
selection
14.Concomitant treatment with intravenous amiodarone from selection
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
judgement
18.Having undergone any form of ablation therapy for AF
19.Patient treated with oral anticoagulant treatment other than vitamin
K antagonist: new oral anticoagulants (dabigatran, rivaroxaban,
apixaban), or treated with irreversible antiplatelet agents P2Y12
inhibitors such as ticlopidine, 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 female patient
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method