Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hydroxychloroquine Sulfate 200 Mg Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
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.
Sites / Locations
- ElectrocardiographRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
hydrochloroquine
Arm Description
receiving radiofrequency ablation and anticoagulant therapy
receiving radiofrequency ablation, anticoagulant therapy and hydrochloroquine treatment (200 mg,bidpo)
Outcomes
Primary Outcome Measures
Recurrence rate of atrial fibrillation after radiofrequency catheter ablation
Recurrence rate of atrial fibrillation after radiofrequency catheter ablation
Secondary Outcome Measures
Side effects
Side effects including Eye diseases, skin damage, death, heart failure, malignant arrhythmia and stroke.
Full Information
NCT ID
NCT03592823
First Posted
June 25, 2018
Last Updated
July 18, 2018
Sponsor
First Affiliated Hospital of Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03592823
Brief Title
Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence
Official Title
Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence After Radiofrequency Catheter Ablation in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
receiving radiofrequency ablation and anticoagulant therapy
Arm Title
hydrochloroquine
Arm Type
Experimental
Arm Description
receiving radiofrequency ablation, anticoagulant therapy and hydrochloroquine treatment (200 mg,bidpo)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate 200 Mg Tablet
Intervention Description
200 mg, bidpo.
Primary Outcome Measure Information:
Title
Recurrence rate of atrial fibrillation after radiofrequency catheter ablation
Description
Recurrence rate of atrial fibrillation after radiofrequency catheter ablation
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Side effects
Description
Side effects including Eye diseases, skin damage, death, heart failure, malignant arrhythmia and stroke.
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Li, MD
Phone
86-451-85555673
Email
ly99ly@vip.163.com
Facility Information:
Facility Name
Electrocardiograph
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Shi, MD
Phone
86-451-85555672
Email
yidashijing@163.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence
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