Actively Recruiting
Rate Control Efficacy in Atrial Fibrillation With Rheumatic Mitral Stenosis: Lenient vs Strict Rate Control Strategies
Led by University of Brawijaya · Updated on 2024-05-10
100
Participants Needed
3
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
University of Brawijaya
Lead Sponsor
S
Saiful Anwar Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Rate Control Efficacy in Atrial Fibrillation With Rheumatic Mitral Stenosis: Lenient vs Strict Rate Control Strategies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have atrial fibrillation and moderate-to-severe rheumatic mitral stenosis confirmed by ECG and echocardiography and diagnosed by a cardiologist
- Have severe rheumatic mitral stenosis and are not eligible for surgery
- Have a mean resting heart rate greater than 80 beats per minute, with or without rate control medication
- Are between 18 and 80 years old
- Provide informed consent to participate in the study
You will not qualify if you...
- Have paroxysmal atrial fibrillation
- Have heart failure with unstable hemodynamics
- Have heart failure classified as NYHA class IV
- Are currently treated for hyperthyroidism and have been euthyroid for less than 3 months
- Have been diagnosed with ischemic or hemorrhagic stroke
- Have symptomatic bradycardia with atrioventricular conduction disturbances
- Use a pacemaker, implantable cardioverter-defibrillator, or are undergoing cardiac resynchronization therapy
- Have malignancy or obstructive sleep apnea
- Have congenital heart defects
- Have atrial fibrillation caused by electrolyte disturbances, hyperthyroidism, or reversible/non-cardiac causes
- Are unable to perform daily physical activities
- Have had coronary artery bypass graft, cardiac surgery, or heart transplant within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Saiful Anwar Hospital
Malang, East Java, Indonesia, 65111
Actively Recruiting
2
Prima Husada Sukorejo Hospital
Pasuruan, East Java, Indonesia, 67161
Not Yet Recruiting
3
Dr. Iskak Regional General Hospital
Tulungagung, East Java, Indonesia, 66223
Actively Recruiting
Research Team
A
Ardian Rizal, MD, FIHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here