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

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ClinicalTrials.gov Identifier: NCT02145546
Recruitment Status : Unknown
Verified May 2014 by Yi-Gang Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : May 23, 2014
Last Update Posted : May 23, 2014
Sponsor:
Collaborators:
Medtronic (Shanghai) Management Co. Ltd.
Beijing CTSmed Co. Ltd
Information provided by (Responsible Party):
Yi-Gang Li, 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Amiodarone Drug: Propafenone Drug: Sotalol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2014
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017


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



Primary Outcome Measures :
  1. Average AF burden in minutes per day [ Time Frame: 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.

  2. Persistent AF free survival rate [ Time Frame: 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 :
  1. Left ventricular function [ Time Frame: 0months, 6months and 12 months ]
    LVEF(Simpson), LV volume, diastolic function (E/A ), tricuspid regurgitation, Left atrial size and volume

  2. SF-36 health survey [ Time Frame: 0 months, 6 months and 12 months ]
    SF-36 health survey

  3. comorbidity and mortality [ Time Frame: 6 months and 12 months ]
    The rate of stroke, infarction, heart failure, rehospitalization and cardiovascular and total mortality rate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145546


Contacts
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Contact: Yi-Gang Li, MD 13761318166 drliyigang@outlook.com
Contact: Bo Liu, MD 13816037607 liuboxinhua@qq.com

Locations
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China, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicne Not yet recruiting
Shanghai, Shanghai, China, 200092
Principal Investigator: Yi-Gang Li, MD         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Medtronic (Shanghai) Management Co. Ltd.
Beijing CTSmed Co. Ltd
Investigators
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Principal Investigator: Yi-Gang Li, MD Xinhua Hospital, Shanghai Jiaotong University School of Medicne

Publications:
Charles D. Swerdlow, Jeffrey M. Gillberg, Paul Khairy, Textbook, Clinical Cardiac Pacing, Defibrillation and Resynchronization Therapy, Chapter 3, Sensing and Detection, page 146.

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Responsible Party: Yi-Gang Li, Chief Physician, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02145546     History of Changes
Other Study ID Numbers: XHEC-C-2013-013-2
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by Yi-Gang Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Pacing dependent
Atrial Fibrillation
Amiodarone
Propafenone
Sotalol
AF burden

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Sotalol
Propafenone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers