NCT00647192终止2 期
EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
University Hospital, Saarland2 个研究点 分布在 2 个国家目标入组 38 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation
研究概览
简要总结
The purpose of this study is to determine whether Eplerenone reduces atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent atrial fibrillation (AF), AF persistence for > 7 days but < 1 year
- •Total AF history < 2 years
- •Written informed consent of the patient
- •Age ≥18 years
- •Female patients are sterilised or postmenopausal or apply an adequate method for contraception (Pearl index <1%) and have a negative pregnancy test (ß-HCG) and do not breastfeed/nurse.
排除标准
- •Hemodynamic instability or symptoms not allowing cardioversion to be delayed for 3 weeks
- •Myocardial infarction within the last 3 months
- •Heart failure NYHA class III - IV
- •Uncontrolled hypertension, defined as a systolic blood pressure > 160 mm Hg and/or a diastolic blood pressure > 95 mm Hg (anti-hypertensive treatment is allowed).
- •Pre-treatment with an aldosterone antagonist or other potassium sparing diuretics
- •Instable angina pectoris
- •Use of Digitalis
- •Use of class I or class III antiarrhythmic drugs (must be stopped at least 5 half-life before)
- •Contraindication or hypersensitivity to ß-blockers
- •Open heart surgery within the last 3 months
- •Pregnancy
- •Acute and reversible illnesses
- •Acute and chronic infection
- •Alcohol or drug abuse or a severe progressive extracardiac disease
- •Untreated manifest and latent hyper- or hypothyroidism or < 3 months peripheral euthyroidism (normal fT3)
- •Moderate to severe renal insufficiency (Creatinine clearance less than 50 ml/min)
- •Patients with liver cirrhosis (Child-Pugh class C)
- •Co-administration of strong CYP3A4 inhibitors (e.g. Itraconazole, Ketoconazole, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin and Nephazodon)
- •Hypersensitivity against Eplerenone and/or one of the other components of the tablet (see Fachinformation)
- •Serum potassium > 5 mmol/l
- •Patients unlikely to comply with the protocol
研究组 & 干预措施
1
Active Comparator
Eplerenone treatment
干预措施: Eplerenone (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation
时间窗: 8 weeks
次要结局
- Sinus rhythm within eplerenone treatment before planned electrical cardioversion(3 weeks)
- Cardioversion success(at least one sinus beat)
- Time to recurrence of atrial fibrillation(8 weeks)
研究者
研究点 (2)
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