Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371222
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-03-19
Brief Title:
Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm - a Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None