2025-524584-20-00招募中3 期
AVISO - Assessment of Flecainide versus Bisoprolol as First-Line Treatment for Premature Ventricular Contractions: a Multicenter Randomized Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 9
- 主要终点
- The primary endpoint is an efficacy endpoint: difference in daily Premature Ventricular Contractions (PVC) burden expressed in % of cardiac beats averaged from a 7-days Holter-ECG monitoring, between the inclusion and the 3 months follow-up periods.
研究概览
简要总结
To evaluate the efficacy of flecainide versus bisoprolol to treat ventricular premature contractions
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years-old
- •≥ 1 symptom (palpitations, presyncope, dyspnea, fatigue) present within a month before inclusion
- •Absence of indication for first line catheter ablation (PVC not easily amenable to catheter ablation or multifocal PVC) OR patient refusal for first-line catheter ablation
- •LVEF ≥ 45% by transthoracic echocardiography of cardiac magnetic resonance imaging
- •Ischemic heart disease ruled out (no myocardial ischemia or significant coronary artery disease at stress ECG or TTE or coronary CT or stress MRI or coronary angiography, performed less than 1-year before randomization)
- •Affiliated to Social Security
- •Signed written consent form
排除标准
- •Familial channelopathy (long QT syndrome, Brugada syndrome, cathecholaminergic polymorphic ventricular tachycardia)
- •Sustained atrial arrhythmia (atrial fibrillation, tachycardia, flutter)
- •Congestive heart failure (signs or symptoms, elevated NT-proBNP)
- •Any of the following abnormality found at electrocardiogram at inclusion visit: presence of QRS width >120 ms, Pre-excitation, any degree of AV-block, except due to enhanced vagal tone (e.g. Wencheback-block at night in young athletes or 1st degree AV block that disappears during exercise)
- •Abnormal liver or kidney function (AST/ALT three times upper normal, eGRF <50 ml/min/m2)
- •Asthma requiring bronchodilation therapy
- •Currently receiving treatment in any other investigational device or drug trial, or less than 30 days since ending treatment on another investigational device or drug trial.
- •Previous hypokalemia (potassium level <3 mmol per liter)
- •Known ongoing pregnancy or lactation for a women of childbearing potential*Known hypersensibility to flecainide or bisoprolol or their excipients (see SmPC of the provided specialities), or contraindications to flecainide or bisoprolol
- •Known hypersensibility to flecainide or bisoprolol or their excipients (see SmPC of the provided specialities), or contraindications to flecainide or bisoprolol
- •Intended use of a prohibited medication
- •Patient under guardianship, judicial protection or curatorship
- •Genetic cardiomyopathy (hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, dilated cardiomyopathy, including genotype positive phenotype negative individuals)
- •Active myocarditis or previous myocarditis with sequalae
- •Sustained ventricular tachycardia (≥30 s)
结局指标
主要结局
The primary endpoint is an efficacy endpoint: difference in daily Premature Ventricular Contractions (PVC) burden expressed in % of cardiac beats averaged from a 7-days Holter-ECG monitoring, between the inclusion and the 3 months follow-up periods.
The primary endpoint is an efficacy endpoint: difference in daily Premature Ventricular Contractions (PVC) burden expressed in % of cardiac beats averaged from a 7-days Holter-ECG monitoring, between the inclusion and the 3 months follow-up periods.
次要结局
- Incidence of the adverse events listed below evaluated at 3 months. • Major: death from any cause, hospitalization for cardiovascular causes, sustained ventricular arrhythmia, fast-conducting (1:1) atrial arrhythmias. • Minor: fatigue, vertigo, blurred vision, tremor, impotence, hypotension or symptomatic sinus bradycardia < 50 bpm, QRS widening >120 ms.
- Difference in Quality of Life assessed by the European Quality of Life–5 Dimensions (EQ-5D) visual analogue scale and the 12-Item Short-Form General Health Survey (SF- 12), between baseline and after 3 months of treatment.
- Need for catheter ablation of PVC.
- Efficacy endpoint (primary endpoint) in specific subtypes such as papillary muscle PVCs, LV summit or multifocal PVCs.
研究者
Mikaël LAREDO
Scientific
Assistance Publique Hopitaux De Paris
研究点 (9)
Loading locations...
相似试验
招募中
4 期
Flecainide Safety in Patients With Coronary Artery Disease and Atrial FibrillationCoronary Artery DiseaseNCT07405671Universitaire Ziekenhuizen KU Leuven988
招募中
3 期
Effect and safety of flecainide and metoprolol alene to suppress ventricular arrhythmias in arrhythmic mitral valve prolapse.2022-500814-24-00Oslo University Hospital Hf50
招募中
4 期
Randomized Evaluation of fleCAinide safety vs. STandard of care in patients with coronary artery disease and Atrial Fibrillation (ReCAST AF).Coronary artery diseaseAtrial fibrillation2025-525121-13-00UZ Leuven988
招募中
3 期
Ivabradine in the Acute Management of Cardiogenic ShockCardiogenic Shock Post Myocardial InfarctionNCT07714746National Institute of Cardiovascular Diseases, Pakistan200
尚未招募
不适用
Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular ComplexesNCT07445334Western Sydney Local Health District40