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Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592823
Recruitment Status : Unknown
Verified June 2018 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Tracking Information
First Submitted Date  ICMJE June 25, 2018
First Posted Date  ICMJE July 19, 2018
Last Update Posted Date July 19, 2018
Estimated Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
Recurrence rate of atrial fibrillation after radiofrequency catheter ablation [ Time Frame: up to 1 year ]
Recurrence rate of atrial fibrillation after radiofrequency catheter ablation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
Side effects [ Time Frame: up to 1 year ]
Side effects including Eye diseases, skin damage, death, heart failure, malignant arrhythmia and stroke.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence
Official Title  ICMJE Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence After Radiofrequency Catheter Ablation in Patients With Atrial Fibrillation
Brief Summary

Atrial fibrillation is the most common arrhythmia in clinic. It can lead to heart failure or stroke, and has a high disability rate and mortality rate. At present, although radiofrequency ablation can cure atrial fibrillation, the success rate is only 50~70%, and has a high recurrence rate. In recent decades, no effective new antiarrhythmic drugs have been introduced, but there are side effects in long-term application of the existing antiarrhythmic drugs. Therefore, it is urgent to provide new and effective antiarrhythmic drugs.

Autophagy level of atrial myocytes in atrial fibrillation patients was significantly higher than that in sinus rhythm. Hydrochloroquine (HCQ) is a hydroxychloroquine sulfate composed of 4- amino quinoline compounds. As an effective inhibitor for autophagy, HCQ could effectively prevent the increased autophagy level of atrial myocytes in atrial fibrillation rabbits, prevent atrial effective refractory period (AERP) shortening, and decrease the rate and duration of atrial fibrillation.

At present, hydroxychloroquine is mainly used in the treatment of rheumatic immune system diseases and anti malaria. Because of its good safety and small side effects, HCQ has become an indispensable member of drugs in the combined treatment of rheumatoid arthritis and systemic lupus erythematosus patients. In recent years, studies have reported that hydroxychloroquine plays an important role in the prevention and treatment of cardiovascular diseases. Chloroquine could effectively shorten the action potential of atrial myocytes by blocking the inward rectifier potassium ion channel (Kir2.1) and reducing the inward potassium ion current Ik1. HCQ could also reduce 72% (P=0.002), and 70% for the risk of coronary heart disease, stroke, and transient ischemic disease. So the investigators speculate that HCQ may be a potential drug to block the occurrence of acute atrial fibrillation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Drug: Hydroxychloroquine Sulfate 200 Mg Tablet
200 mg, bidpo.
Study Arms  ICMJE
  • No Intervention: control
    receiving radiofrequency ablation and anticoagulant therapy
  • Experimental: hydrochloroquine
    receiving radiofrequency ablation, anticoagulant therapy and hydrochloroquine treatment (200 mg,bidpo)
    Intervention: Drug: Hydroxychloroquine Sulfate 200 Mg Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 18, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Successful radiofrequency ablation of atrial fibrillation within 24 hours

Exclusion Criteria:

  • History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and transient ischemic attack.
  • History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.
  • History of renal impairment.
  • History of Type I diabetes mellitus or Type II diabetes uncontrolled.
  • History of liver impairment.
  • History of alcoholism or drug abuse.
  • Known severe skin rash or damage.
  • Known retinal pigmentation and visual field defect.
  • Allergy to any component of hydroxychloroquine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03592823
Other Study ID Numbers  ICMJE AF-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party First Affiliated Hospital of Harbin Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Harbin Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account First Affiliated Hospital of Harbin Medical University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP