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NCT06409533

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
University of Brawijaya·ClinicalTrials.gov·otherRecruiting
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Study focus
Disease/Condition
Atrial Fibrillation,Rheumatic Mitral Stenosis,Arrhythmias, Cardiac
Drug/Device/Intervention
Rate control
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
University of Brawijaya
Location
Malang,Pasuruan,Tulung Agung, Indonesia
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2023
End date
Dec 01, 2024
Enrollment
100 participants
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
Chronic atrial fibrillationPersistent atrial fibrillationMitral stenosisAtrial fibrillation and atrial flutter, unspecifiedAtrial fibrillation and flutter
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06409533
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.