Rate Control Efficacy in Atrial Fibrillation With Rheumatic Mitral Stenosis: Lenient vs Strict Rate Control Strategies - Trial NCT06409533
Access comprehensive clinical trial information for NCT06409533 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Brawijaya and is currently Recruiting. The study focuses on Atrial Fibrillation,Rheumatic Mitral Stenosis,Arrhythmias, Cardiac. Target enrollment is 100 participants.
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Study Focus
Sponsor & Location
University of Brawijaya
Timeline & Enrollment
N/A
Mar 01, 2023
Dec 01, 2024
Primary Outcome
Number of Hospitalizations,Quality of Life as Measured by the Short Form-36 (SF-36) Questionnaire,Functional Capacity as Measured by 6-Minutes Walk Test (6MWT)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06409533
Non-Device Trial