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临床试验/NCT06371222
NCT06371222已完成4 期

Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm - a Randomized Control Trial

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
effect of ivabradine in MS patients

研究概览

简要总结

Mitral stenosis, a condition characterized by narrowing of the mitral valve orifice, remains a significant cause of morbidity and mortality worldwide, particularly in regions where rheumatic fever is endemic. Despite advancements in medical and surgical management, patients with mitral stenosis often suffer from symptoms such as dyspnea, fatigue, and reduced exercise tolerance, significantly impacting their quality of life (QoL) [1].

One of the hallmark features of mitral stenosis is the development of sinus rhythm, which can be associated with elevated heart rates due to decreased diastolic filling time and compensatory mechanisms to maintain cardiac output. Persistent tachycardia in patients with mitral stenosis contributes to increased myocardial oxygen demand, exacerbating symptoms and potentially leading to adverse outcomes [2].

In recent years, ivabradine, a selective inhibitor of the If current in the sinoatrial node, has emerged as a promising therapeutic option for controlling heart rate in various cardiovascular conditions, including chronic heart failure and ischemic heart disease [3]. By specifically targeting the cardiac pacemaker cells, ivabradine reduces heart rate without affecting myocardial contractility or conduction, offering a unique mechanism of heart rate control compared to traditional beta-blockers or calcium channel blockers [4].

However, the role of ivabradine in patients with mitral stenosis in sinus rhythm remains uncertain, and there is limited evidence regarding its efficacy and impact on QoL in this specific patient population. Therefore, the aim of this randomized controlled trial (RCT) is to investigate the effects of ivabradine on heart rate control and QoL in patients with mitral stenosis in sinus rhythm.

详细描述

Symptoms of mitral stenosis (MS) are may be sometimes cause significant risk mainly during increase heart and exercise. Beta-blockers are given in some patients for heart rate (HR) in MS, which in turn improve the symptoms, but they have side effects. Ivabradine has a selective action on the sinus node with less side effects. Some studies have recently investigated the role of ivabradine in MS in sinus rhythm. We will determine the efficacy and safety status of ivabradine, compared to standard treatment on maximum HR achieved among patients in sinus rhythm with MS as well as the impact of drug treatment on QOL.

Research question:

What is the role of ivabradine in comparison with standard treatment (beta blocker) on heart rate in sinus rhythm and quality of life in mitral stenosis patients?

Aims and Objectives:

General:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
17 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sex- male and females
  • MS patients admitted to BSMMU
  • All patients who will give written informed consent
  • Diagnosis of Mitral stenosis by ECG & Echo
  • Mitral stenosis patients with heart rate above 80bpm
  • trans thoracic echocardiography mitral valve area >1.5 cm2

排除标准

  • Significant others valvular or congenital heart disease
  • Prior history of MI, Coronary intervention or CABG
  • Heart failure
  • Previous cardiac surgery
  • Any form of cardiomyopathy
  • Conduction defect
  • Haemodynamically unstable patient and patient with an unstable co-morbid illness
  • Renal impairment
  • COVID-19 patient
  • Urgent need for surgical treatment or balloon valvoplasty
  • Patients who have indication for surgical treatment or BMV
  • Heart failure
  • Sick sinus syndrome patients
  • Pregnancy
  • Atrial fibrillation
  • Patient with blood pressure systolic < 90 and diastolic < 50 mm of Hg

研究组 & 干预措施

controlled group

Active Comparator

controlled group

干预措施: Beta blocker (Drug)

intervention group

Experimental

intervention group

干预措施: Ivabradine (Drug)

结局指标

主要结局

effect of ivabradine in MS patients

时间窗: three months

effect of ivabradine from baseline with the study drugs on heart rate

次要结局

  • quality of life of MS patients(three months)

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Skeikh Foyez Ahmed

consultant cardilogist

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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