Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence
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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
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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.
Condition or disease | Intervention/treatment | Phase |
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Atrial Fibrillation | Drug: Hydroxychloroquine Sulfate 200 Mg Tablet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Care Provider, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence After Radiofrequency Catheter Ablation in Patients With Atrial Fibrillation |
Estimated Study Start Date : | August 1, 2018 |
Estimated Primary Completion Date : | December 31, 2019 |
Estimated Study Completion Date : | August 1, 2020 |

Arm | Intervention/treatment |
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No Intervention: control
receiving radiofrequency ablation and anticoagulant therapy
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Experimental: hydrochloroquine
receiving radiofrequency ablation, anticoagulant therapy and hydrochloroquine treatment (200 mg,bidpo)
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Drug: Hydroxychloroquine Sulfate 200 Mg Tablet
200 mg, bidpo. |
- Recurrence rate of atrial fibrillation after radiofrequency catheter ablation [ Time Frame: up to 1 year ]Recurrence rate of atrial fibrillation after radiofrequency catheter ablation
- Side effects [ Time Frame: up to 1 year ]Side effects including Eye diseases, skin damage, death, heart failure, malignant arrhythmia and stroke.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592823
Contact: Yue Li, MD | 86-451-85555673 | ly99ly@vip.163.com |
China, Heilongjiang | |
Electrocardiograph | Recruiting |
Harbin, Heilongjiang, China, 150001 | |
Contact: Jing Shi, MD 86-451-85555672 yidashijing@163.com |
Responsible Party: | First Affiliated Hospital of Harbin Medical University |
ClinicalTrials.gov Identifier: | NCT03592823 |
Other Study ID Numbers: |
AF-1 |
First Posted: | July 19, 2018 Key Record Dates |
Last Update Posted: | July 19, 2018 |
Last Verified: | June 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Atrial Fibrillation Recurrence Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Disease Attributes Hydroxychloroquine |
Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |