2023-510362-26-00招募中4 期
Carvedilol vs. flecainida clinical trial in idiopathic ventricular arrhythmias.
Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年4月2日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Difference between both groups in the average value of the ratio formed by dividing the number of ventricular beats measured in the 24-h Holter-ECG performed before starting treatment divided by the number of ventricular beats measured in the 24-h Holter-ECG performed after after completing treatment.
研究概览
简要总结
Compare between both treatments the average value of the ratio formed by dividing the number of ventricular latives measured in the 24-h Holter-ECG performed before starting the treatment divided by the number of ventricular latives measured in the 24-h Holter-ECG performed after to complete the treatment.
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
- •Patients of legal age capable of consenting.
排除标准
- •Allergy or adverse effects after previously taking flecainide and/or carvedilol.
- •Significant heart failure secondary to tachemocardiopathy.
- •History of structural heart disease, including: ischemic heart disease, moderate or severe valvular disease, moderate or severe left ventricular hypertrophy, cardiac surgery, sarcoidosis, congenital heart disease (including Brugada syndrome, long QT syndrome, short QT syndrome, cardiomyopathy and other less common conditions).
- •Sinus dysfunction in patients who do not have pacemakers.
- •Presence of accessory roads.
- •Pregnancy and breastfeeding, since carvedilol is a drug that has been little studied in this context, which should be avoided if other alternatives are available.
- •Having received electrophysiological procedures will only be an exclusion criterion if it was performed to ablate malignant ventricular arrhythmias.
- •Previous intake of flecainide and/or beta-blockers at therapeutic doses with the same indication as in the study. Patients in whom low doses are started and referred without adequate titration will not be excluded.
- •Little arrhythmic load in Holter-electrocardiogram (Holter-ECG) that does not explain the patient's symptoms. Patients with less than 1000 ventricular beats on the 24-h Holter-ECG will not be accepted.
- •Liver failure.
- •Chronic kidney disease with glomerular filtration rate <30 ml/m2/min.
- •Second or third degree atrioventricular block.
- •First degree atrioventricular block with PR >220 ms.
- •Duration of the QRS complex >120 ms.
- •Moderately or severely depressed left ventricular ejection fraction (<40%).
结局指标
主要结局
Difference between both groups in the average value of the ratio formed by dividing the number of ventricular beats measured in the 24-h Holter-ECG performed before starting treatment divided by the number of ventricular beats measured in the 24-h Holter-ECG performed after after completing treatment.
Difference between both groups in the average value of the ratio formed by dividing the number of ventricular beats measured in the 24-h Holter-ECG performed before starting treatment divided by the number of ventricular beats measured in the 24-h Holter-ECG performed after after completing treatment.
次要结局
- Comparison of the absolute reduction in the number of ventricular beats measured on the 24-h Holter before starting each treatment vs. after reaching the target doses. Analysis will be performed by intention to treat.
- Comparison of the % reduction of ectopic ventricular beats over the total number of beats recorded before starting each treatment vs. ECG obtained immediately before stopping said drug, with the previously titrated dose.
- Comparison of the percentage of patients who achieve a reduction in the number of ventricular extrasystoles greater than 80% in absolute number between both groups.
- A subgroup study will be carried out for the primary variable depending on the origin of the ventricular arrhythmia.
- Improvement in quality of life with the SF36 questionnaire.
- Change in LVEF and GLS strain (global longitudinal strain) of the left ventricle between the baseline TTE and that performed at the end of treatment with each drug.
- Number of patients who present any adverse effect during follow-up with each drug.
- Number of patients with serious adverse effects with each drug. We will understand serious adverse effects as all those that require admission or cause the death of the patient.
- Descriptives of the pathology.
研究者
Moisés Rodríguez Mañero
Scientific
Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
研究点 (1)
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