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

NCT06409533 | Recruiting

• 1 other identifier: 400/011/K.3/102.7/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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

Atrial Fibrillation; Rheumatic Mitral Stenosis; Arrhythmias, Cardiac

Keywords

Atrial Fibrillation; Mitral Stenosis; Rheumatic Heart Disease; Heart Rate Control; Rate Control

Outcome Measures

Primary Outcomes (3)

• Number of Hospitalizations

  Patients were hospitalized at least once during the follow-up period due to worsening functional class, treated at the research hospital or at other facilities. Primary data were obtained based on the results of interviews with patients and/or their families, as well as from medical record data (numerical scale).

  0-3 months

• Quality of Life as Measured by the Short Form-36 (SF-36) Questionnaire

  The SF-36 is a validated, patient-reported survey used widely to measure health-related quality of life. It encompasses eight scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The SF-36 will be measured at the end of follow up period.

  3 months

• Functional Capacity as Measured by 6-Minutes Walk Test (6MWT)

  The 6MWT is a well-established, practical test widely used in clinical settings to assess the exercise tolerance and functional status of patients, particularly those with cardiovascular and pulmonary conditions. The 6MWT will be administered at the end of the study period, which is 3 months from baseline.

  3 months

Secondary Outcomes (4)

• Change of Quality of Life as Measured by the Short Form-36 (SF-36) Questionnaire

  0-3 months

• Change of Functional Capacity as Measured by 6-Minutes Walk Test (6MWT)

  0-3 months

• Change of Metabolic Equivalents (METs) as Estimated from 6-Minutes Walk Test (6MWT)

  0-3 months

• Change of VO2max as Estimated from 6-Minutes Walk Test (6MWT)

  0-3 months

Study Arms (2)

Strict Rate Control

EXPERIMENTAL

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.

Other: Rate control

Lenient Rate Control

ACTIVE COMPARATOR

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.

Other: Rate control

Interventions

Rate control OTHER

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.

Lenient Rate Control; Strict Rate Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brawijaya: lead
• Saiful Anwar Hospital: collaborator

Study Sites (3)

Saiful Anwar Hospital

Malang, East Java, 65111, Indonesia

RECRUITING

Prima Husada Sukorejo Hospital

Pasuruan, East Java, 67161, Indonesia

NOT YET RECRUITING

Dr. Iskak Regional General Hospital

Tulungagung, East Java, 66223, Indonesia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Mitral Valve Stenosis; Arrhythmias, Cardiac; Rheumatic Heart Disease

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Valve Diseases; Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ardian Rizal, MD, FIHA

  University of Brawijaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ardian Rizal, MD, FIHA

CONTACT

+62 341-362101; drardianrizal@ub.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This trial implemented a double-masking protocol involving both the patients (participants) and the outcome assessors. Patients (participants) were unaware of their group assignment and the specific heart rate targets set for them. While the treating physicians (care providers) were informed about the heart rate control targets for their respective patients, the outcome assessors remained blinded to the participants' group allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ardian Rizal, MD, FIHA. Assistant Professor of Arrhythmia, Department of Cardiology and Vascular Medicine, Faculty of Medicine.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: March 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)