Mitral StenosisPhase 4NCT06371222
Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm
A Phase 4 study testing Ivabradine and Beta blocker in people with Mitral Stenosis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Mitral Stenosis
- What is being tested?
- Ivabradine and Beta blocker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm - a Randomized Control Trial
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].
Read more
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.
Read the 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:
- To evaluate the effect of ivabradine on heart rate at base line and after 3 months in sinus rhythm mitral stenosis patients
- 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
- To assess the comparative safety of ivabradine and beta blocker in sinus rhythm in mitral stenosis patients
- 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
- Conditions
- Mitral Stenosis
- Being tested
- Ivabradine, Beta blocker
- Medical subject headings
- Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
5 mg for 3 months
Beta blockerDrug
Also called metoprolol
controlled group
| Study group | Role | What they receive |
|---|---|---|
| controlled group | Active comparator | controlled group Receives: Drug: Beta blocker |
| intervention group | Experimental | intervention group Receives: Drug: Ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of ivabradine in MS patients
effect of ivabradine from baseline with the study drugs on heart rate
Measured: three months
Secondary outcomes (1)
quality of life of MS patients
Questionnaire to assess quality of life changes
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Feb 2023
- Primary completion31 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Skeikh Foyez Ahmed, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- sheikh dr ahmed, MD, Principal investigator, BSMMU, DHAKA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371222
- Sponsor's protocol ID
- BSMMU/2023/6502
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06371222
- Acronym / sponsor ID
- BSMMU/2023/6502
- Conditions
- Mitral Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To evaluate the effect of ivabradine on heart rate at base line and after 3 months in sinus rhythm mitral stenosis patients
- 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
- To assess the comparative safety of ivabradine and beta blocker in sinus rhythm in mitral stenosis patients
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| controlled group | Active comparator | Drug: Beta blockercontrolled group |
| intervention group | Experimental | Drug: Ivabradineintervention group |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- Significant others valvular or congenital heart disease
- Prior history of MI, Coronary intervention or CABG
- Heart failure
- Previous cardiac surgery
- Any form of cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivabradine5 mg for 3 months | Drug | intervention group |
| Beta blockerAlso: metoprololcontrolled group | Drug | controlled group |
Primary outcome
effect of ivabradine in MS patients
Time frame: three months
effect of ivabradine from baseline with the study drugs on heart rate
1 secondary outcome
quality of life of MS patients
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sheikh dr ahmed, MD principal investigator
BSMMU, DHAKA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivabradine and Beta blocker in people with Mitral Stenosis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of ivabradine in MS patients (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.