Comparing strict and lenient heart rate control in patients with atrial fibrillation and rheumatic mitral stenosis
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
This study is testing whether controlling heart rates strictly or more loosely helps people with atrial fibrillation and rheumatic mitral stenosis feel better and stay out of the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Brawijaya Academic / other |
| Locations | 3 sites (Malang, East Java and 2 other locations) |
| Trial ID | NCT06409533 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two heart rate control strategies—strict (60-80 bpm) and lenient (81-110 bpm)—in patients suffering from atrial fibrillation associated with rheumatic mitral stenosis. The study will assess whether these differing approaches can reduce hospitalizations, improve quality of life, and enhance physical functional capacities. Participants will be monitored for clinical outcomes, including rehospitalization rates and overall well-being, to determine the optimal heart rate management strategy for this patient population. The trial addresses a significant gap in existing research by focusing specifically on patients with rheumatic mitral stenosis and atrial fibrillation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with moderate-to-severe rheumatic mitral stenosis and atrial fibrillation.
Not a fit: Patients with paroxysmal atrial fibrillation or those with unstable heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with atrial fibrillation and rheumatic mitral stenosis, enhancing their quality of life and reducing hospitalizations.
How similar studies have performed: While previous studies have shown the non-inferiority of lenient rate control in other populations, this specific approach in patients with rheumatic mitral stenosis and atrial fibrillation has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Malang, East Java and 2 other locations
- Saiful Anwar Hospital — Malang, East Java, Indonesia (Recruiting)
- Prima Husada Sukorejo Hospital — Pasuruan, East Java, Indonesia (Not_yet_recruiting)
- Dr. Iskak Regional General Hospital — Tulungagung, East Java, Indonesia (Recruiting)
Study contacts
- Principal investigator: Ardian Rizal, MD, FIHA — University of Brawijaya
- Study coordinator: Ardian Rizal, MD, FIHA
- Email: drardianrizal@ub.ac.id
- Phone: +62 341-362101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.