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

NCT06371222 | Completed Phase 4 DMC

• 1 other identifier: BSMMU/2023/6502
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Stenosis

Outcome Measures

Primary Outcomes (1)

• effect of ivabradine in MS patients

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

  three months

Secondary Outcomes (1)

• quality of life of MS patients

  three months

Study Arms (2)

controlled group

ACTIVE COMPARATOR

controlled group

Drug: Beta blocker

intervention group

EXPERIMENTAL

intervention group

Drug: Ivabradine

Interventions

Ivabradine DRUG

5 mg for 3 months

intervention group

Beta blocker DRUG

controlled group

Also known as: metoprolol

controlled group

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, 1200, Bangladesh

Location

MeSH Terms

Conditions

Mitral Valve Stenosis

Interventions

Ivabradine; Adrenergic beta-Antagonists; Metoprolol

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• sheikh dr ahmed, MD

  BSMMU, DHAKA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant cardilogist

Model Details: RCT

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 17, 2024
• Study Start: February 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 1, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)