Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation (ADA-PAF)

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Amiodarone; Drug: Propafenone; Drug: Sotalol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02145546

XHEC-C-2013-013-2

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

  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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

Amiodarone

Experimental group

Description:

Patient will take Amiodarone orally

Treatment:

Drug: Amiodarone

Sotalol

Experimental group

Description:

Patients will take sotalol orally

Treatment:

Drug: Sotalol

Propafenone

Experimental group

Description:

Patients will take propafenone orally

Treatment:

Drug: Propafenone

Control

No Intervention group

Description:

Patients will take no antiarrhythmic drugs except β-blocker