EUCTR2009-011291-29-GB进行中（未招募）不适用
Routine versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3 - RACE 3 study: Intensive vs. usual rhythm control for AF, Version 1
Interuniversity Cardiology Institute of the Netherlands (ICIN)0 个研究点目标入组 250 人开始时间: 2011年8月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- •- Early symptomatic persistent AF defined as: 1. total AF history < 2 years, and 2. total persistent AF duration > 7 days and < 6 months, and 3. = 1 previous ECV - Mild to moderate early HF, defined as: 1. Total HF history < 1 year, and 2. One of the following: ? LVEF = 45% and NYHA II-III, and normal pulmonary function and body mass •Previously documented HF-related NT-proBNP elevation (> 400 ng/l (=48 pmol/l)), or •Evidence of structural heart disease including LV hypertrophy (posterior wall and/or septum diameter = 11 mm or = 10 mm using Penn’s method as in MUMC) or regional LV dysfunction (akinesia, hypokinesia), or •Previous admission for HF, or •Evidence of diastolic dysfunction on echocardiography (average annular e’ <8 cm/s, ánd deceleration time > 220 ms, ánd average E/e’ > 8 or in case of color coded TDI E/e’ > 11) ? LVEF 25-45% and NYHA class I-III - Optimal documentation and treatment of underlying heart disease; - No contra-indication for oral anticoagulation; - Eligible for cardiovascular rehabilitation program; - Age = 40 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- On waiting list for PVI or expected to be placed on waiting list for PVI within one year; - Symptoms not allowing ECV to be delayed for 3 weeks; - HF NYHA functional class IV; - LVEF < 25%. - Left atrial size > 50 mm (parasternal axis); - Severe valvular disease (previous valve repair/replacement is permitted); - Present ARA use; - Patients with cardiac resynchronization therapy; - Previous use of continuous prophylactic class I or class III antiarrhythmic drugs (except for sotalol, which should be discontinued at inclusion and replaced with beta-blocker); - Postoperative AF; - Myocardial infarction within last 3 months; - Hypersensitivity against ARAs; - Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg and/or a diastolic blood pressure > 95 mmHg (anti-hypertensive treatment is allowed); - Unstable angina pectoris; - Open heart surgery within the last 3 months; - Serum potassium > 5 mmol/l; - 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 euthyroidism; - Moderate to severe renal insufficiency (creatinine clearance less than 50 ml/min); - Patients with liver cirrhosis (Child-Pugh class C) or repeated ALT/AST 1.5 times the upper limit or other significant liver disease; - Co-administration of strong CYP3A4 inhibitors (i.e. grapefruit juice, ketoconazol, itraconazol, posaconazol, voriconazol, claritromycine, erytromycine, telitromycine, indinavir, nelfinavir, ritonavir, saquinavir, HIV-protease inhibitors) or strong CYP3A4 inductors (i.e. carbamazepine, rifampicine, St John’s wort [St Janskruid]); - Pregnancy; - Complex congenital heart diseases. The only congenital heart diseases that can be included are atrial septal defect, ventricular septal defect, bicuspid aortic stenosis; - Patients unlikely to comply with the protocol.
研究者
相似试验
进行中（未招募）
不适用
Routine versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3 - RACE 3EUCTR2009-011291-29-NLInteruniversity Cardiology Institute Netherlands
招募中
不适用
Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)Atrial fibrillationNL-OMON22526MUMC+490
尚未招募
不适用
Comparing the effect of two different physiotherapy techniques on grip strength, pinch strength and dexterity of hand among middle aged healthy individuals.CTRI/2021/02/031381KLE Academy of Higher Education and Research
招募中
不适用
Chronotype and rhythm stability using activity and sleep in chronic diseasessleep disruption in chronic diseasesDRKS00033622Medizinische Fakultät der Heinrich Heine Universität444
招募中
不适用
Device-based rate versus rhythm control treatment in patients with symptomatic recent-onset atrial fibrillation in the emergency department (RACE 9)cardiac arrhythmia10007521atrial fibrillationNL-OMON55214Medisch Universitair Ziekenhuis Maastricht490