UnknownNot Applicable

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

Indonesia100 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range

18 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: * Participants with atrial fibrillation and moderate-to-severe rheumatic mitral stenosis, as confirmed by ECG and echocardiography and diagnosed by the attending cardiologist. * Patients with atrial fibrillation and severe rheumatic mitral stenosis who are ineligible for surgical intervention. * Mean resting heart rate \> 80 bpm, with or without the use of rate control medication. * Age range between 18 and 80 years. * Provision of informed consent by participants. Exclusion Criteria: * Patients with paroxysmal atrial fibrillation. * Heart failure (HF) with unstable hemodynamics. * HF classified as NYHA (New York Heart Association) class IV. * Patients currently undergoing treatment for hyperthyroidism who have been euthyroid for \< 3 months. * Individuals diagnosed with a stroke, either ischemic or hemorrhagic. * Symptomatic bradycardia accompanied by AV (atrioventricular) conduction disturbances. * Use of a pacemaker, implantable cardioverter-defibrillator (ICD), or undergoing cardiac resynchronization therapy (CRT). * Diagnosis of malignancy or obstructive sleep apnea (OSA). * Patients with congenital heart defects. * Atrial fibrillation secondary to electrolyte disturbances, hyperthyroidism, or reversible/non-cardiac causes. * Inability to perform daily physical activities. * Patients who have undergone CABG (coronary artery bypass graft), cardiac surgery, or a heart transplant within the past three months.

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

Number of Hospitalizations

Timeframe: 0-3 months

Quality of Life as Measured by the Short Form-36 (SF-36) Questionnaire

Timeframe: 3 months

Functional Capacity as Measured by 6-Minutes Walk Test (6MWT)

Timeframe: 3 months

Trial details

NCT IDNCT06409533

SponsorUniversity of Brawijaya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10

Contact for this trial

Ardian Rizal, MD, FIHA

+62 341-362101 drardianrizal@ub.ac.id

View on ClinicalTrials.gov More Atrial Fibrillation trials