NCT02145546

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline
Completed

Started May 2014

Typical duration for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

3 years

First QC Date

April 2, 2014

Last Update Submit

May 20, 2014

Conditions

Atrial Fibrillation

Keywords

Pacing dependentAtrial FibrillationAmiodaronePropafenoneSotalolAF burden

Outcome Measures

Primary Outcomes (2)

  • 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.

    monthly up to 12 months

  • Persistent AF free survival rate

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

    monthly up to12 months

Secondary Outcomes (3)

  • Left ventricular function

    0months, 6months and 12 months

  • SF-36 health survey

    0 months, 6 months and 12 months

  • comorbidity and mortality

    6 months and 12 months

Study Arms (4)

Amiodarone

EXPERIMENTAL

Patient will take Amiodarone orally

Drug: Amiodarone

Sotalol

EXPERIMENTAL

Patients will take sotalol orally

Drug: Sotalol

Propafenone

EXPERIMENTAL

Patients will take propafenone orally

Drug: Propafenone

Control

NO INTERVENTION

Patients will take no antiarrhythmic drugs except β-blocker

Interventions

AmiodaroneDRUG

Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.

Also known as: cordarone, pacerone, aratac, arycor, atlansil, tachyra
Amiodarone
PropafenoneDRUG

150mg per 8 hours, 3 times per day

Also known as: rythmol SR, rytmonorm
Propafenone
SotalolDRUG

80mg twice per day.

Also known as: betapace, betapace AF, sotalex, sotacor
Sotalol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicne

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (11)

  • OSTRANDER LD Jr, BRANDT RL, KJELSBERG MO, EPSTEIN FH. ELECTROCARDIOGRAPHIC FINDINGS AMONG THE ADULT POPULATION OF A TOTAL NATURAL COMMUNITY, TECUMSEH, MICHIGAN. Circulation. 1965 Jun;31:888-98. doi: 10.1161/01.cir.31.6.888. No abstract available.

    PMID: 14297523BACKGROUND

  • Zhou ZQ, Hu DY, Chen J, Zhang RH, Li KB, Zhao XL. [An epidemiological survey of atrial fibrillation in China]. Zhonghua Nei Ke Za Zhi. 2004 Jul;43(7):491-4. Chinese.

    PMID: 15312400BACKGROUND

  • Siu CW, Jim MH, Zhang X, Chan YH, Pong V, Kwok J, Kung AW, Lau CP, Tse HF. Comparison of atrial fibrillation recurrence rates after successful electrical cardioversion in patients with hyperthyroidism-induced versus non-hyperthyroidism-induced persistent atrial fibrillation. Am J Cardiol. 2009 Feb 15;103(4):540-3. doi: 10.1016/j.amjcard.2008.10.019. Epub 2008 Dec 25.

    PMID: 19195517BACKGROUND

  • Singh BN, Singh SN, Reda DJ, Tang XC, Lopez B, Harris CL, Fletcher RD, Sharma SC, Atwood JE, Jacobson AK, Lewis HD Jr, Raisch DW, Ezekowitz MD; Sotalol Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T) Investigators. Amiodarone versus sotalol for atrial fibrillation. N Engl J Med. 2005 May 5;352(18):1861-72. doi: 10.1056/NEJMoa041705.

    PMID: 15872201BACKGROUND

  • Roy D, Talajic M, Dorian P, Connolly S, Eisenberg MJ, Green M, Kus T, Lambert J, Dubuc M, Gagne P, Nattel S, Thibault B. Amiodarone to prevent recurrence of atrial fibrillation. Canadian Trial of Atrial Fibrillation Investigators. N Engl J Med. 2000 Mar 30;342(13):913-20. doi: 10.1056/NEJM200003303421302.

    PMID: 10738049BACKGROUND

  • Pritchett EL, Page RL, Carlson M, Undesser K, Fava G; Rythmol Atrial Fibrillation Trial (RAFT) Investigators. Efficacy and safety of sustained-release propafenone (propafenone SR) for patients with atrial fibrillation. Am J Cardiol. 2003 Oct 15;92(8):941-6. doi: 10.1016/s0002-9149(03)00974-3.

    PMID: 14556870BACKGROUND

  • Israel CW. Analysis of mode switching algorithms in dual chamber pacemakers. Pacing Clin Electrophysiol. 2002 Mar;25(3):380-93. doi: 10.1046/j.1460-9592.2002.00380.x.

    PMID: 11990674BACKGROUND

  • Passman RS, Weinberg KM, Freher M, Denes P, Schaechter A, Goldberger JJ, Kadish AH. Accuracy of mode switch algorithms for detection of atrial tachyarrhythmias. J Cardiovasc Electrophysiol. 2004 Jul;15(7):773-7. doi: 10.1046/j.1540-8167.2004.03537.x.

    PMID: 15250860BACKGROUND

  • Kaufman ES, Israel CW, Nair GM, Armaganijan L, Divakaramenon S, Mairesse GH, Brandes A, Crystal E, Costantini O, Sandhu RK, Parkash R, Connolly SJ, Hohnloser SH, Healey JS; ASSERT Steering Committee and Investigators. Positive predictive value of device-detected atrial high-rate episodes at different rates and durations: an analysis from ASSERT. Heart Rhythm. 2012 Aug;9(8):1241-6. doi: 10.1016/j.hrthm.2012.03.017. Epub 2012 Mar 20.

    PMID: 22440154BACKGROUND

  • Nowak B, McMeekin J, Knops M, Wille B, Schroder E, Moro C, Oelher M, Castellanos E, Coutu B, Petersen B, Pfeil W, Kreuzer J; Stored EGM in PulsarMax II and Discovery II Study Group. Validation of dual-chamber pacemaker diagnostic data using dual-channel stored electrograms. Pacing Clin Electrophysiol. 2005 Jul;28(7):620-9. doi: 10.1111/j.1540-8159.2005.00159.x.

    PMID: 16008796BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

AmiodaronePropafenoneSotalol

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropiophenonesKetonesOrganic ChemicalsEthanolaminesAmino AlcoholsAlcoholsAmines

Study Officials

  • Yi-Gang Li, MD

    Xinhua Hospital, Shanghai Jiaotong University School of Medicne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Gang Li, MD

CONTACT

13761318166drliyigang@outlook.com

Bo Liu, MD

CONTACT

13816037607liuboxinhua@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 2, 2014

First Posted

May 23, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 23, 2014

Record last verified: 2014-05

Locations

CN(1)