The Comparison With Clinical Impacts on Functional Capacity and Symptom Improvement According to the Rhythm Control in Patients With Heart Failure and Recent Onset Atrial Fibrillation

Study Overview
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Brief Summary
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Prospective randomized (rhythm control or rate control in heart failure patients with new onset atrial fibrillation) Objective of study 1. To analyze long term outcome of patients with heart failure with new onset atrial fibrillation according to the rhythm control 2. To analyze remodeling of atrium and ventricle by the new onset AF in heart failure patients 3. To analyze the change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF

Conditions
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Heart Failure, Recent Onset Atrial Fibrillation

Intervention / Treatment
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* Procedure: Sinus Rhythm control
* Procedure: Pulse Rate control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Heart failure and Atrial fibrillation within 1year (20 80 years old) LA diameter < 5mm LVEF 20 49% patients possible to anticoagulation and anti arrhythmic drug Expected survival >1yr Exclusion Criteria: Impossible to anticoagulation or anti arrhythmic drug valvular atrial fibrillation ( Mitral valve stenosis, Mitral valve plasty, valve replacement) LV ejection fraction < 20% Structural cardiac disease Catheter ablation history for AF, maze surgery patient with severe medical disease Impossible to anticoagulation or anti arrhythmic drug

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sinus Rhythm Control group<br>Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation Cardioversion after 1 month Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) If AF recur, RFCA | Procedure: Sinus Rhythm control<br> <br> |
| Active Comparator: Pulse Rate Control Group<br>No AAD, just anticoagulation HR control between 60 110bpm (with beta blocker, calcium channel blocker, digoxin) Without the treatment about antiarrhythmia and rhythm control, diffraction of rate control, the subject will be drop out for study. | Procedure: Pulse Rate control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation | ejection fraction change (echocardiography) | 1 year | 
| functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation | peak VO2 (cardio pulmonary test ; CPX) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remodeling of atrium by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF | Echo cardiography (LV ejection fraction, LV wall thickness, LV mass index, LA dimension, LA appendage velocity, E/E'), EKG, 24 hours Holter recording | 1 years late | 
| remodeling of ventricle by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF | Echo cardiography (LV ejection fraction, LV wall thickness, LV mass index, LA dimension, LA appendage velocity, E/E'), EKG, 24 hours Holter recording | 1 years late |