Clinical Trial Summary
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.
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:
To assess and compare the status of ivabradine with beta blocker on heart rate in sinus
rhythm in mitral stenosis patients
Specific:
1. To evaluate the effect of ivabradine on heart rate at base line and after 3 months in
sinus rhythm mitral stenosis patients
2. To assess the comparative efficacy of ivabradine versus beta blocker on heart rate at
baseline and after 3 months in sinus rhythm in mitral stenosis patients
3. To assess the comparative safety of ivabradine and beta blocker in sinus rhythm in
mitral stenosis patients
4. To assess & compare the effect of ivabradine with beta blocker on quality of life in
sinus rhythm mitral stenosis patients
Additional Objective
• To measure LVEF by bedside 2D & M mode echocardiography
