ADA-PAF: Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02145546

Collaborator

Medtronic (Shanghai) Management Co. Ltd. (Industry), Beijing CTSmed Co. Ltd (Other)

600

Enrollment

Location

Arms

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Amiodarone Drug: Propafenone Drug: Sotalol	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

May 1, 2017

Anticipated Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amiodarone Patient will take Amiodarone orally	Drug: Amiodarone Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study. Other Names: cordarone pacerone aratac arycor atlansil tachyra
Experimental: Sotalol Patients will take sotalol orally	Drug: Sotalol 80mg twice per day. Other Names: betapace betapace AF sotalex sotacor
Experimental: Propafenone Patients will take propafenone orally	Drug: Propafenone 150mg per 8 hours, 3 times per day Other Names: rythmol SR rytmonorm
No Intervention: Control Patients will take no antiarrhythmic drugs except β-blocker

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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