Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence

Atrial Fibrillation Clinical Trial

Official title:

Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence After Radiofrequency Catheter Ablation in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03592823
• Other study ID #: AF-1
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: June 2018
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Yue Li, MD
• Phone: 86-451-85555673
• Email: ly99ly[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Drug:
• Hydroxychloroquine Sulfate 200 Mg Tablet
200 mg, bidpo.

Locations

Country	Name	City	State
China	Electrocardiograph	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of atrial fibrillation after radiofrequency catheter ablation	Recurrence rate of atrial fibrillation after radiofrequency catheter ablation	up to 1 year
Secondary	Side effects	Side effects including Eye diseases, skin damage, death, heart failure, malignant arrhythmia and stroke.	up to 1 year