Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ADA-PAF  

Official title:

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02145546
• Other study ID #: XHEC-C-2013-013-2
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 2, 2014
• Last updated: May 20, 2014
• Start date: May 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2014
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yi-Gang Li, MD
• Phone: 13761318166
• Email: drliyigang[@]outlook.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Amiodarone
Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.
• Propafenone
150mg per 8 hours, 3 times per day
• Sotalol
80mg twice per day.

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicne	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Beijing CTSmed Co. Ltd, Medtronic (Shanghai) Management Co. Ltd.

Country where clinical trial is conducted

China, 

References & Publications (11)

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

Israel CW. Analysis of mode switching algorithms in dual chamber pacemakers. Pacing Clin Electrophysiol. 2002 Mar;25(3):380-93. Review. — View Citation

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. — View Citation

Nowak B, McMeekin J, Knops M, Wille B, Schröder 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Roy D, Talajic M, Dorian P, Connolly S, Eisenberg MJ, Green M, Kus T, Lambert J, Dubuc M, Gagné 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Left ventricular function	LVEF(Simpson), LV volume, diastolic function (E/A ), tricuspid regurgitation, Left atrial size and volume	0months, 6months and 12 months	No
Secondary	SF-36 health survey	SF-36 health survey	0 months, 6 months and 12 months	No
Secondary	comorbidity and mortality	The rate of stroke, infarction, heart failure, rehospitalization and cardiovascular and total mortality rate.	6 months and 12 months	No