Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The current evidences indicate that  30% patients with sick sinus syndrome(SSS) would develop persistent atrial fibrillation (AF) after a long term pacing therapy. However, the accurate influence of antiarrhythmic drugs on the AF is still not well defined. The purpose of the study is to assess the therapeutic effects of various antiarrhythmic drugs (Amiodarone, Sotalol and Propafenone) on the long term management of AF in SSS patients with AF, including the reduced AF burden (duration and episodes) and persistent AF free survival rate. All patients will be followed up for 12 months.

Official Title
-----------------
Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Amiodarone
* Drug: Propafenone
* Drug: Sotalol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old sick sinus syndrome with pacemaker Class I or Class IIa indication has a pacemaker which can provide the daily AF burden monitor record for at least 28 days has at AF record in the past 6 months, the valid AF record includes any of at least one 30 seconds AF holter record at least one 15 seconds 12-ECG record at least 5 minutes long AF episodes record from pacemakers able and willing to give informed consent Exclusion Criteria: will have cardiac surgery in the next 6 month or in the waiting list of heart transplantation NYHA Class III or IV LVEF <50% Reversible AF, such as AF caused by hyperthyroidism or severe postoperative atrial fibrillation Persistence AF Expected life expectancy less than 1 year Planned to be pregnant or be in the feeding period in the next year Non-stable, decompensated heart failure Allergy to Amiodarone, Propafenone or Sotalol Cancer Clear liver damage ( ALT and/or AST > 2*normal limit) Patients with cardiogenic shock history Be in the treatment of Amiodarone for more than 3 months or less than 3 months with Amiodarone wash out period less than 30 days Coronary artery disease (CHD), cardiomyopathy, severe valvular heart disease, severe obstructive pulmonary disease (COPD), long QT syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amiodarone<br>Patient will take Amiodarone orally | Drug: Amiodarone<br>* Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.<br>* Other names: tachyra;|
| Experimental: Sotalol<br>Patients will take sotalol orally | Drug: Sotalol<br>* 80mg twice per day.<br>* Other names: sotacor;|
| Experimental: Propafenone<br>Patients will take propafenone orally | Drug: Propafenone<br>* 150mg per 8 hours, 3 times per day<br>* Other names: rytmonorm;|
| No Intervention: Control<br>Patients will take no antiarrhythmic drugs except β-blocker | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average AF burden in minutes per day | Long term usages of test drug reduce AF burden, including the number and accumulated total time of AF per day. | monthly up to 12 months | 
| Persistent AF free survival rate | Long term usages of test drugs reduce the occurence of the persistent AF ( the persistent AF survival rate)。 | monthly up to12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular function | LVEF(Simpson), LV volume, diastolic function (E/A ), tricuspid regurgitation, Left atrial size and volume | 0months, 6months and 12 months | 
| SF-36 health survey | SF-36 health survey | 0 months, 6 months and 12 months | 
| comorbidity and mortality | The rate of stroke, infarction, heart failure, rehospitalization and cardiovascular and total mortality rate. | 6 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacing dependent, Atrial Fibrillation, Amiodarone, Propafenone, Sotalol, AF burden