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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Number of Hospitalizations
研究概览
简要总结
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.
详细描述
Rheumatic Heart Disease (RHD) often begins with untreated Group A Streptococcal infections leading to acute rheumatic fever and potentially progressing to Mitral Stenosis (MS), a condition characterized by the narrowing of the mitral valve that disrupts normal blood flow and increases atrial pressure. This pathology is closely associated with Atrial Fibrillation (AF), the most common arrhythmia in patients with MS, affecting 30-40% of such patients, with prevalence increasing with age and disease duration. The management of AF in this group focuses on anticoagulation to prevent thromboembolic events and heart rate control through medications like beta-blockers and digitalis to improve symptoms and cardiac efficiency.
Despite the guidance provided by the Rate Control Efficacy in Permanent Atrial Fibrillation (RACE II) trial, which showed non-inferiority of lenient rate control (resting heart rate <110 bpm) compared to strict control (resting heart rate <80 bpm) in reducing cardiovascular morbidity and mortality, no studies have specifically explored these strategies in patients with AF and rheumatic MS. This research gap underscores the importance of our study, aiming to assess the safety and efficacy of lenient versus strict rate control in this distinct clinical subset, potentially offering critical insights that could lead to optimized, personalized treatment protocols for these high-risk patients.
The objective of this clinical trial is to evaluate the effectiveness of different heart rate control strategies in improving clinical outcomes for patients with atrial fibrillation associated with rheumatic mitral stenosis. The outcomes of interest include reducing hospitalizations, enhancing quality of life, and improving functional capacities within three months follow-up period. The study compares two heart rate control strategies: strict control, with a target resting heart rate of 60-80 beats per minute (bpm), and lenient control, with a target resting heart rate of 81-110 bpm. The primary research questions 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 quality of life in these patients?
- Does lenient versus strict heart rate control enhance their functional capacity?
To determine whether one strategy is non-inferior to the other, researchers will compare strict and lenient rate control outcomes. Participants will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Hospitalizations
时间窗: 0-3 months
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).
Quality of Life as Measured by the Short Form-36 (SF-36) Questionnaire
时间窗: 3 months
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.
Functional Capacity as Measured by 6-Minutes Walk Test (6MWT)
时间窗: 3 months
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.
次要结局
- 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)
研究者
Ardian Rizal
Ardian Rizal, MD, FIHA. Assistant Professor of Arrhythmia, Department of Cardiology and Vascular Medicine, Faculty of Medicine.
University of Brawijaya