NCT00392613已完成不适用
RAte Control Efficacy in Permanent Atrial Fibrillation, a Comparison Between Lenient Versus Strict Rate Control in Patients With and Without Heart Failure.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Cardiovascular mortality
研究概览
简要总结
The investigators hypothesis is that in patients with permanent AF lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality, morbidity, neurohormonal activation, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs. Lenient rate control is defined as a resting heart rate <110 bpm.Strict rate control is defined as a mean resting heart rate < 80 beats per minute (bpm) and heart rate during minor exercise < 110 bpm. Patients will be seen after 1, 2, 3 months (for titration of rate control drugs) and thereafter yearly.
详细描述
Study objectives:
- To show that lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality and morbidity
- To show that lenient rate control is not inferior to strict rate control in terms of all cause mortality, cardiovascular hospitalizations, NYHA class for exercise tolerance, left ventricular function and left atrial size, quality of life, neurohormonal activation as measured by NT-proBNP, hospitalization for heart failure, syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, and pacemaker implantations, stroke, systemic emboli, and bleeding, unstable angina pectoris and myocardial infarction, costs and renal function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a current episode of permanent AF < 12 months.
- •Age </= 80 years.
- •Mean resting heart rate > 80 beats per minute with or without rate control medication
- •Oral anticoagulation (or aspirin if no risk factors for thromboembolic complications are present).
排除标准
- •Paroxysmal AF
- •Known contra-indications for either strict or lenient rate control (e.g. previous adverse effects on negative chronotropic drugs).
- •Unstable heart failure defined as NYHA IV heart failure and heart failure necessitating hospital admission < 3 months before inclusion.
- •Cardiac surgery < 3 months.
- •Any stroke.
- •Current or foreseen pacemaker and/ or cardiac resynchronization therapy.
- •Signs of sick sinus syndrome or AV conduction disturbances (i.e. symptomatic bradycardia or asystole > 3 seconds or escape rate < 40 beats per minute in awake symptom-free patients).
- •Untreated hyperthyroidism or < 3 months euthyroidism.
- •Inability to walk or bike.
结局指标
主要结局
Cardiovascular mortality
Heart failure
Stroke
Bleeding
Syncope
Ventricular tachycardia
PM / ICD implantation
Cardiac arrest
Life-threatening adverse effects of RC drugs
次要结局
- All cause mortality
- All cause hospitalizations
- Exercise tolerance
- LV function and left atrial size
- Quality of life
- NT-proBNP
- Costs
- Renal function
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Rate Control Efficacy in permanent atrial fibrillation, a comparison between lenient verus strict rate control in patients with and without heart failure.NL-OMON29392etherlands Heart FoundationInteruniversity Cardioly Institute the NetherlandsAstraZenecaAventis SanofiBiotronikGuidantMedtronicRocheVitatron500
已完成
不适用
Rate Control Efficacy in permanent atrial fibrillation, a comparison between lenient versus strict rate control in patients with and without heart failureAtrial fibrillationISRCTN36532482niversity Medical Center Groningen (UMCG) (Netherlands)500
已完成
不适用
Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart FailureAtrial FibrillationNCT00877643I.C. Van Gelder250
已完成
4 期
Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF)Permanent Atrial FibrillationNCT02391337University of Birmingham161
招募中
不适用
Rate Control Efficacy in Atrial Fibrillation With Rheumatic Mitral Stenosis: Lenient vs Strict Rate Control StrategiesRheumatic Mitral StenosisArrhythmias, CardiacAtrial FibrillationNCT06409533University of Brawijaya100