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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Amiodarone
Propafenone
Sotalol
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Pacing dependent, Atrial Fibrillation, Amiodarone, Propafenone, Sotalol, AF burden

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Amiodarone

Sotalol

Propafenone

Control

Arm Description

Patient will take Amiodarone orally

Patients will take sotalol orally

Patients will take propafenone orally

Patients will take no antiarrhythmic drugs except β-blocker

Outcomes

Primary Outcome Measures

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.
Persistent AF free survival rate
Long term usages of test drugs reduce the occurence of the persistent AF ( the persistent AF survival rate)。

Secondary Outcome Measures

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

Full Information

First Posted
April 2, 2014
Last Updated
May 20, 2014
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Medtronic (Shanghai) Management Co. Ltd., Beijing CTSmed Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02145546
Brief Title
Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation
Acronym
ADA-PAF
Official Title
Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Medtronic (Shanghai) Management Co. Ltd., Beijing CTSmed Co. Ltd

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Pacing dependent, Atrial Fibrillation, Amiodarone, Propafenone, Sotalol, AF burden

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amiodarone
Arm Type
Experimental
Arm Description
Patient will take Amiodarone orally
Arm Title
Sotalol
Arm Type
Experimental
Arm Description
Patients will take sotalol orally
Arm Title
Propafenone
Arm Type
Experimental
Arm Description
Patients will take propafenone orally
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will take no antiarrhythmic drugs except β-blocker
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Other Intervention Name(s)
cordarone, pacerone, aratac, arycor, atlansil, tachyra
Intervention Description
Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.
Intervention Type
Drug
Intervention Name(s)
Propafenone
Other Intervention Name(s)
rythmol SR, rytmonorm
Intervention Description
150mg per 8 hours, 3 times per day
Intervention Type
Drug
Intervention Name(s)
Sotalol
Other Intervention Name(s)
betapace, betapace AF, sotalex, sotacor
Intervention Description
80mg twice per day.
Primary Outcome Measure Information:
Title
Average AF burden in minutes per day
Description
Long term usages of test drug reduce AF burden, including the number and accumulated total time of AF per day.
Time Frame
monthly up to 12 months
Title
Persistent AF free survival rate
Description
Long term usages of test drugs reduce the occurence of the persistent AF ( the persistent AF survival rate)。
Time Frame
monthly up to12 months
Secondary Outcome Measure Information:
Title
Left ventricular function
Description
LVEF(Simpson), LV volume, diastolic function (E/A ), tricuspid regurgitation, Left atrial size and volume
Time Frame
0months, 6months and 12 months
Title
SF-36 health survey
Description
SF-36 health survey
Time Frame
0 months, 6 months and 12 months
Title
comorbidity and mortality
Description
The rate of stroke, infarction, heart failure, rehospitalization and cardiovascular and total mortality rate.
Time Frame
6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Gang Li, MD
Phone
13761318166
Email
drliyigang@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Liu, MD
Phone
13816037607
Email
liuboxinhua@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Gang Li, MD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiaotong University School of Medicne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital, Shanghai Jiao Tong University School of Medicne
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Gang Li, MD

12. IPD Sharing Statement

Citations:
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14297523
Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

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