Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

Phase 4

• Conditions: Atrial Fibrillation
• Interventions: Drug: Amiodarone; Drug: Sotalol; Drug: Propafenone

• Registration Number: NCT02145546
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-02
• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-20
• Last Update Submitted: 2014-05-20
• Study First Posted: 2014-05-23
• Last Update Posted: 2014-05-23
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

  1. at least one 30 seconds AF holter record
  2. at least one 15 seconds 12-ECG record
  3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amiodarone	Amiodarone	Patient will take Amiodarone orally
Sotalol	Sotalol	Patients will take sotalol orally
Propafenone	Propafenone	Patients will take propafenone orally

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicne; 🇨🇳 Shanghai, Shanghai, China