Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in exercise tolerance with and without metoprolol
研究概览
简要总结
In this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation. The investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury.
详细描述
In this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation.
The investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury.
The investigators will enroll 50 patients that will meet all the inclusion criteria and will agree to participate in the trial. In patients with preceding beta-blocker medication, it will be discontinued and a washout period of one month will be provided. The investigators will assess baseline characteristics and then divide patients randomly into two arms based on their date of birth (even/odd days of the month).
Arm A will be given metoprolol 50 mg daily for three months, after this period the effect will be evaluated and metoprolol discontinued. A month-long washout period will follow and after an additional three months without metoprolol medication, patients will be reevaluated.
Arm B will be without metoprolol for three months and will be evaluated thereafter. Then the patients will be given metoprolol 50 mg daily for three months followed by a reevaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients post alcohol septal ablation
- •Pressure gradient in left ventricular outflow tract <30 mmHg
- •Written consent to participate
排除标准
- •History of atrial fibrillation
- •Symptoms of Class III or IV of New York Heart Association functional classification
- •Permanent pacemaker implant
- •Age above 75
研究组 & 干预措施
metoprolol-no metoprolol
After a washout period of one month following discontinuation of preceding beta-blocker medication patients will be given metoprolol 50 mg daily. The effect will be evaluated after three months of treatment. After that, another one-month washout period will commence followed by three months without metoprolol medication. Then, a final reevaluation will be performed.
干预措施: Metoprolol (Drug)
no metoprolol-metoprol
After a one-month washout period following discontinuation of preceding beta-blocker medication patients will continue another three months without a metoprolol medication. After that, an evaluation will be performed. Then they will be given metoprolol 50 mg daily for three months followed by a reevaluation.
干预措施: Metoprolol (Drug)
结局指标
主要结局
Change in exercise tolerance with and without metoprolol
时间窗: At baseline, after three months of metoprolol medication, after three months without metoprolol medication
VO2max during bicycle ergometer exercise test
次要结局
- Change in left ventricular diastolic function at rest with and without metoprolol(After three months of metoprolol medication, after three months without metoprolol medication)
- Change in exercise induced pressure gradient in left ventricular outflow tract with and without metoprolol(After three months of metoprolol medication, after three months without metoprolol medication)
- Change of concentration of a biomarker of myocardial injury with and without metoprolol(After three months of metoprolol medication, after three months without metoprolol medication)
- Change of quality of life with and without metoprolol: The Kansas City Cardiomyopathy Questionnaire(After three months of metoprolol medication, after three months without metoprolol medication)
- Change of concentration of biomarker of heart failure with and without metoprolol(After three months of metoprolol medication, after three months without metoprolol medication)
研究者
Hana Hnátová
medical doctor, resident in cardiology department
University Hospital, Motol