EUCTR2018-001936-23-ES进行中（未招募）1 期
A multicenter, randomized, open-label, phase III clinical trial to compare the efficacy and safety of Ivabradine versus Digoxine in the chronic control of heart rate in patients with permanent atrial fibrillation under treatment with beta-blockers or calcium antagonists.(IvaBRAdine blocK of funny current for heart rate control in permanEnt Atrial Fibrillation). BRAKE-AF study. - BRAKE-AF study
Dr. Adolfo Fontenla Cerezuela0 个研究点目标入组 0 人开始时间: 2018年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Age equal to or greater than 18 years.
- •2. Permanent FA at the time of randomization, with no prospect of cardioversion, antiarrhythmic treatment with group I or III drugs, or pulmonary vein ablation.
- •3. Symptoms attributable to AF associated with the presence of at least one of the following inadequate FC control criteria:
- •a) HR at rest> 110 bpm (on ECG performed in the 14 days prior to inclusion).
- •b) HR at rest between 80 and 110 bpm (on ECG performed in the 14 days prior to inclusion) and at least one of the following criteria:
- •i. HR in exercise of moderate intensity> 130 bpm (measured in an ergometry or in a Holter-ECG performed in the 60 days prior to inclusion).
- •ii. Average daytime HR = 80 bpm (measured on a Holter-ECG performed in the 60 days prior to inclusion).
- •4. Be receiving treatment with beta-blockers or non-dihydropyridine calcium channel blockers (verapamil or diltiazem) at the maximum dose recommended or tolerated by the patient.
- •5. Be able to voluntarily give their informed consent (the subject himself, his legal representative or an impartial witness).
- •6. Blood test carried out in the 6 months prior to inclusion, including: blood count, thyroid hormones and creatinine, in order to rule out secondary causes of poor FC control. The creatinine figure will be used to calculate the creatinine clearance in order to adjust the dose of patients who are randomized to the Digoxin group.
- •7. Transthoracic echocardiogram to rule out, eg, severe valvular heart disease, hypertrophic cardiomyopathy. The one performed in the year prior to inclusion in the study will be considered acceptable provided that the patient's clinical situation has been stable in that period of time.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1. Previous treatment or known contraindication to Ivabradine or Digoxin.
- •2. Paroxysmal or intermittent complete AV block in patients not carrying a pacemaker.
- •3. Decompensated heart failure requiring inotropic and / or intravenous diuretics in the week prior to randomization or in NYHA functional class IV or on the cardiac transplant waiting list.
- •4. Acute pericarditis, acute myocarditis or constrictive pericarditis.
- •5. Obstructive hypertrophic cardiomyopathy.
- •6. Valvular disease requiring surgical or percutaneous correction.
- •7. Medical causes that justify poor control of heart rate: fever, anemia, hyperthyroidism, pheochromocytoma, etc.
- •8. Severe hypotension (blood pressure <90/50 mmHg).
- •9. Concomitant treatment with potent cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone.
- •10. Severe renal insufficiency (CrCl <30 ml / Kg / min) or in a hemodialysis program.
- •11. Severe hepatic insufficiency.
- •12. Major surgery (including cardiac surgery) in the month prior to randomization.
- •13. Severe concomitant illness that supposes a life expectancy of less than one year.
- •14. Impossibility of carrying out scheduled visits to the protocol.
- •15. Suspected pregnancy or confirmed pregnancy.
- •16. Participation in a clinical trial in the previous 6 months.
研究者
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