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

NCT06409533 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Rate 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.

Sponsors & Collaborators

  • Saiful Anwar Hospital

    collaborator OTHER

  • University of Brawijaya

    lead OTHER

Principal Investigators

  • Ardian Rizal, MD, FIHA · University of Brawijaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06409533 on ClinicalTrials.gov