EUCTR2012-003487-48-CZ进行中（未招募）1 期
Efficacy and safety study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Demographic Characteristics and Other Baseline Characteristics:
- •1.Men or women aged more than 18 years (inclusive),
- •2.Patients with current 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 disfunction 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 <
- •7.On appropriate, stable medical treatments for heart failure, including a
- •diuretic and/or angiotensin-converting enzyme, and/or angiotensinreceptor
- •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
- 另有 2 项未显示
排除标准
- •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
- •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
- •17.Dietary supplement with ? 3 or ? 6 according to investigator's
- •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
研究者
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