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

Atrial Fibrillation Arrhythmias, Cardiac Rheumatic Mitral Stenosis

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

Inclusion Criteria5

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 Criteria12

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.

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.