Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-28

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this pilot study is to explore the efficacy of chloroquine in terminating persistent AF and assess its potential role as a pharmacological cardioversion agent for the management of AF.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence

NCT03592823

Atrial Fibrillation

UNKNOWN PHASE4

A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation

NCT00540787

Paroxysmal Atrial Fibrillation

COMPLETED PHASE4

Use of Colchicine to Decrease Atrial Fibrillation Recurrence After Ablation

NCT05459974

Atrial Fibrillation

UNKNOWN PHASE3

Prevention Of Recurrence Of Atrial Fibrillation

NCT00041496

Fibrillation, Atrial

COMPLETED PHASE2

AF at Home: A Virtual Education Program for Patients With Atrial Fibrillation (AF)

NCT05810896

Atrial Fibrillation

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open-label, pilot study to explore the efficacy of chloroquine in terminating persistent AF within 2 weeks of drug administration and assess its potential role as a pharmacological cardioversion agent for the management of AF. Subjects will be followed for 2 weeks from the start of drug administration to study drug termination.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chloroquine Phosphate

Chloroquine Phosphate will be provided at 500 mg dosage strength for oral administration. Patient will be instructed to take 2 tablets per day on the first two days and 1 tablet each day for the next 12 days for a total of 14 days treatment.

Group Type EXPERIMENTAL

Chloroquine Phosphate

Intervention Type DRUG

Two tablets of study drug are to be taken on the day of study drug initiation and the next day, followed by one tablet each day for the next 12 days. Study drug to be orally administered and taken with food.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chloroquine Phosphate

Two tablets of study drug are to be taken on the day of study drug initiation and the next day, followed by one tablet each day for the next 12 days. Study drug to be orally administered and taken with food.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18 years and older
2. History of symptomatic persistent AF Persistent AF - defined as continuous AF that is sustained more than 7 days but less than 12 months. Episodes of AF of ≥ 48 hours duration in which a decision is made to terminate with electrical or pharmacological cardioversion prior to 7 days will also be classified as persistent AF
3. AF must be documented at least once either by ECG, event monitoring, loop recorder, telemetry, trans-telephonic monitoring, pacemaker or cardiac defibrillator readouts within 24 months prior to enrollment
4. Currently on anticoagulation therapy as indicated per local guidelines, which is considered optimal for stroke prevention in the opinion of the investigator
5. Implanted dual chamber pacemaker/ICD capable of monitoring atrial arrhythmias or willingness to wear a 2 weeks event monitor if patient does not have a device capable of monitoring atrial arrhythmias
6. Signed informed consent

Exclusion Criteria

1. Age \< 18 years
2. AF felt to be secondary to an obvious reversible cause such as, but not limited to, acute myocardial infarction, pulmonary embolism, recent surgery, pericarditis, alcohol intoxication, hypoxemia, or thyrotoxicosis
3. Structural heart disease including patients with artificial heart valves or valvular AF
4. Obstructive coronary artery disease or history of any myocardial infarction
5. Ejection fraction \< 50% within 1 year of consent
6. Severe or moderate to severe aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation per PI discretion
7. Prolonged QTc of \>460 msec on baseline ECG
8. Contraindications to quinolines
9. Known allergy or hypersensitivity to Chloroquine
10. Use of amiodarone 12 months prior to enrollment
11. History of AF ablation within 30 days prior to enrollment
12. Renal impairment (eGFR \< 30 mL/min/1.73 m2 or Serum Creatinine \> 1.25 mg/dL) for subjects over the age of 65
13. Hepatic disease (ALT/AST 2X the upper normal limit)
14. History of alcohol abuse and/or drug abuse per PI discretion
15. Pre-existing auditory damage
16. History of epilepsy
17. Women of child-bearing potential (those who have had a menstrual period in the previous 12 months) who:

* are pregnant or breast-feeding or plan to become pregnant during study or
* who are not surgically sterile and are not practicing two acceptable methods of birth control, or do not plan to continue practicing two acceptable methods of birth control throughout the study (highly effective methods are listed under section 6.0 Pregnancy)
18. Current participation in another clinical study
19. Serious or active medical or psychiatric condition which, in the opinion of the investigator, may interfere with treatment, assessment, or compliance with the protocol
20. Not able to discontinue medications known to have significant interactions with chloroquine

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No