CompletedPhase 4

Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm

Bangladesh42 participantsStarted 2023-02-01

Plain-language 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.

Who can participate

Age range

17 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥ 18 * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

effect of ivabradine in MS patients

Timeframe: three months

Trial details

NCT IDNCT06371222

SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-31

View on ClinicalTrials.gov More Mitral Stenosis trials