RecruitingNot ApplicableNCT06409533

Rate Control Efficacy in Atrial Fibrillation With Rheumatic Mitral Stenosis: Lenient vs Strict Rate Control Strategies

Rate Control Efficacy in Atrial Fibrillation With Rheumatic Mitral Stenosis: Assessing Clinical Outcomes of Lenient Versus Strict Heart Rate Control in Reducing Hospitalizations, Improving Quality of Life, and Enhancing Functional Capacity


Sponsor

University of Brawijaya

Enrollment

100 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if different types of heart rate control work to improve the clinical outcomes of patients with atrial fibrillation related to rheumatic mitral stenosis in terms of reducing hospitalizations, improving quality of life, and enhancing physical functional capacities. The two types of heart rate (HR) control are strict (resting HR of 60-80 bpm) versus lenient (resting HR of 81-110 bpm) rate control strategies. The main questions it aims to answer are: * Can lenient versus strict heart rate control reduce rehospitalization in patients with atrial fibrillation and rheumatic mitral stenosis? * Does lenient versus strict heart rate control improve the quality of life (QoL) in patients with atrial fibrillation and rheumatic mitral stenosis? * Does lenient versus strict heart rate control enhance functional capacity in patients with atrial fibrillation and rheumatic mitral stenosis? Researchers will compare strict rate control to lenient rate control to see if a particular rate control strategy is non-inferior to the other. Participants will: * Take standardized drugs as per PERKI (Indonesian Heart Association) guidelines for Atrial Fibrillation, which would be either beta-blockers, digoxin, or in combination. This standardized treatment of Atrial Fibrillation will be monitored once every month to see if the dose needs to be titrated in order to reach targeted heart rate control. * After the target of HR control is reached, the participant will be followed up every two weeks via telephone to check for any signs and symptoms. * Furthermore, after the HR target is reached, the participant will visit the cardiology outpatient clinics once every month for 3 consecutive months to see the clinical outcomes of hospitalization, QoL via SF-36 questionnaire, and functional capacities with 6MWT (6-minute walk test). * Additionally, the cardiac function would be evaluated by echocardiography at the baseline (time of enrollment) and at the end of the follow up period.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests which medication is most effective at controlling heart rate in patients with atrial fibrillation (an irregular, rapid heartbeat) who also have severe rheumatic mitral stenosis (a narrowing of the heart's mitral valve caused by rheumatic fever). Heart rate control is particularly challenging in this combination. **You may be eligible if...** - You are 18 to 80 years old - You have atrial fibrillation combined with moderate-to-severe rheumatic mitral stenosis, confirmed by ECG and echocardiogram - Your resting heart rate is above 80 beats per minute **You may NOT be eligible if...** - You have the intermittent (paroxysmal) form of atrial fibrillation - You are in unstable heart failure - You are pregnant - You have severe kidney or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRate control

Patients diagnosed with atrial fibrillation due to moderate to severe rheumatic mitral stenosis (AF-RMS) and undergoing treatment will receive care in accordance with the PERKI (Indonesian Heart Association) guidelines for Atrial Fibrillation. The selection and titration of rate control medications, including β-blockers, digoxin, or their combination, will be managed by the attending cardiologists (care providers) to achieve the target rate control.


Locations(3)

Saiful Anwar Hospital

Malang, East Java, Indonesia

Prima Husada Sukorejo Hospital

Pasuruan, East Java, Indonesia

Dr. Iskak Regional General Hospital

Tulungagung, East Java, Indonesia

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NCT06409533


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