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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
Saiful Anwar Hospital
RECRUITING
Malang
Prima Husada Sukorejo Hospital
NOT_YET_RECRUITING
Pasuruan
Dr. Iskak Regional General Hospital
RECRUITING
Tulungagung
Contact Information
Primary
Ardian Rizal, MD, FIHA
drardianrizal@ub.ac.id
+62 341-362101
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 100
Treatments
Experimental: Strict Rate Control
Physicians will aim for a resting heart rate of 60 to 80 beats per minute, as recorded by a 12-lead resting ECG after the patient has rested for 15 minutes, with the measurement taken over a one-minute period.
Active_comparator: Lenient Rate Control
Physicians will aim for a resting heart rate of 81 to 110 beats per minute, as recorded by a 12-lead resting ECG after the patient has rested for 15 minutes, with the measurement taken over a one-minute period.
Related Therapeutic Areas
Sponsors
Collaborators: Saiful Anwar Hospital
Leads: University of Brawijaya

This content was sourced from clinicaltrials.gov