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Atrial FibrillationPhase 4ADA-PAFNCT02145546

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

A Phase 4 study testing Amiodarone, Propafenone and Sotalol in people with Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Amiodarone, Propafenone and Sotalol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteChina
Study dates
May 2014to May 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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 locations and contacts

1 site in 1 country.

Yi-Gang Li, MD contact

13761318166

drliyigang@outlook.com

Bo Liu, MD contact

13816037607

liuboxinhua@qq.com

China1 site

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicne

    Shanghai, Shanghai Municipality, 200092

    Yi-Gang Li, MD

Other trials in China

About this study

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.

Being tested
Amiodarone, Propafenone, Sotalol
Keywords
Pacing dependent, Atrial Fibrillation, Amiodarone, Propafenone, Sotalol, AF burden
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmiodaroneDrug

    Also called cordarone, pacerone, aratac, arycor

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

  • PropafenoneDrug

    Also called rythmol SR, rytmonorm

    150mg per 8 hours, 3 times per day

  • SotalolDrug

    Also called betapace, betapace AF, sotalex, sotacor

    80mg twice per day.

Study groups in NCT02145546
Study groupRoleWhat they receive
AmiodaroneExperimentalPatient will take Amiodarone orally
Receives: Drug: Amiodarone
SotalolExperimentalPatients will take sotalol orally
Receives: Drug: Sotalol
PropafenoneExperimentalPatients will take propafenone orally
Receives: Drug: Propafenone
ControlNo interventionPatients will take no antiarrhythmic drugs except β-blocker

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: monthly up to 12 months

  2. Persistent AF free survival rate

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

    Measured: monthly up to12 months

Secondary outcomes (3)

  1. Left ventricular function

    LVEF(Simpson), LV volume, diastolic function (E/A ), tricuspid regurgitation, Left atrial size and volume

    Measured: 0months, 6months and 12 months

  2. SF-36 health survey

    SF-36 health survey

    Measured: 0 months, 6 months and 12 months

  3. comorbidity and mortality

    The rate of stroke, infarction, heart failure, rehospitalization and cardiovascular and total mortality rate.

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMay 2017 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02145546
Sponsor's protocol ID
XHEC-C-2013-013-2
Acronym
ADA-PAF
Status last verified
May 2014
First submitted
2 Apr 2014
Last updated
23 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14297523

  • 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.

    PubMed 15312400

  • 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.

    PubMed 19195517

  • 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.

    PubMed 15872201

  • 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.

    PubMed 10738049

  • 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.

    PubMed 14556870

  • 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.

    PubMed 11990674

  • 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.

    PubMed 15250860

  • 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.

    PubMed 22440154

  • 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.

    PubMed 16008796

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amiodarone, Propafenone and Sotalol in people with Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yi-Gang Li, MD (13761318166, drliyigang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average AF burden in minutes per day (time frame: monthly up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02145546, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.

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