Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409533
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Brief Title:
Rate Control Efficacy in Atrial Fibrillation With Rheumatic Mitral Stenosis Lenient vs Strict Rate Control Strategies
Sponsor:
University of Brawijaya
Organization:
University of Brawijaya
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RACE-MS
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
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
Detailed Description:
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
Receive standardized pharmacological treatment according to the PERKI Indonesian Heart Association guidelines for Atrial Fibrillation potentially including beta-blockers digoxin or a combination thereof This treatment regimen will be monitored monthly to adjust dosages and achieve the targeted heart rate
Once the target heart rate is achieved participants will undergo bi-weekly telephone follow-ups to monitor for any signs and symptoms
Additionally after reaching the heart rate target participants will attend monthly follow-up visits at the cardiology outpatient clinic for three consecutive months to assess clinical outcomes including hospitalization rates quality of life via the SF-36 questionnaire and functional capacity using the 6-minute walk test 6MWT
Cardiac function will be evaluated through echocardiography at the time of enrollment and at the end of the follow-up period
The study has been approved by Health Research Ethics Committee from the main hospital Saiful Anwar Hospital and the satellite hospitals ie Dr Iskak Regional General Hospital and Prima Husada Sukorejo Hospital The participants and the outcome assessors will be blinded to ensure the objectiveness whereas the care providers would oversee the standardized treatments and heart rate control targets
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
Receive standardized pharmacological treatment according to the PERKI Indonesian Heart Association guidelines for Atrial Fibrillation potentially including beta-blockers digoxin or a combination thereof This treatment regimen will be monitored monthly to adjust dosages and achieve the targeted heart rate
Once the target heart rate is achieved participants will undergo bi-weekly telephone follow-ups to monitor for any signs and symptoms
Additionally after reaching the heart rate target participants will attend monthly follow-up visits at the cardiology outpatient clinic for three consecutive months to assess clinical outcomes including hospitalization rates quality of life via the SF-36 questionnaire and functional capacity using the 6-minute walk test 6MWT
Cardiac function will be evaluated through echocardiography at the time of enrollment and at the end of the follow-up period
The study has been approved by Health Research Ethics Committee from the main hospital Saiful Anwar Hospital and the satellite hospitals ie Dr Iskak Regional General Hospital and Prima Husada Sukorejo Hospital The participants and the outcome assessors will be blinded to ensure the objectiveness whereas the care providers would oversee the standardized treatments and heart rate control targets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None