EUCTR2012-003487-48-IT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. - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
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
- •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 :
- •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 a month 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 a month after the end of the study.
- •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 122
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •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 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, 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 < 30 mL/min) at selection
- •8.Bradycardia (HR ? 50 bpm)
- •9.Hyperkalemia or hypokalemia (K>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
- •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 judgement
- •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
- •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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