Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence

NCT ID: NCT03592823

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-08-01

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

control

receiving radiofrequency ablation and anticoagulant therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

hydrochloroquine

receiving radiofrequency ablation, anticoagulant therapy and hydrochloroquine treatment (200 mg,bidpo)

Group Type: EXPERIMENTAL

Hydroxychloroquine Sulfate 200 Mg Tablet

Intervention Type: DRUG

200 mg, bidpo.

Interventions

Hydroxychloroquine Sulfate 200 Mg Tablet

200 mg, bidpo.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Electrocardiograph

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yue Li, MD

Role: CONTACT

ly99ly@vip.163.com

86-451-85555673

Facility Contacts

Jing Shi, MD

Role: primary

yidashijing@163.com

86-451-85555672

Other Identifiers

AF-1

Identifier Type: -

Identifier Source: org_study_id