RecruitingPhase 2NCT02932007

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

Sponsor

University of South Florida

Enrollment

40 participants

Start Date

Mar 28, 2017

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Age 18 years and older
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
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
Currently on anticoagulation therapy as indicated per local guidelines, which is considered optimal for stroke prevention in the opinion of the investigator
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
Signed informed consent

Exclusion Criteria22

Age \< 18 years
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
Structural heart disease including patients with artificial heart valves or valvular AF
Obstructive coronary artery disease or history of any myocardial infarction
Ejection fraction \< 50% within 1 year of consent
Severe or moderate to severe aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation per PI discretion
Prolonged QTc of \>460 msec on baseline ECG
Contraindications to quinolines
Known allergy or hypersensitivity to Chloroquine
Use of amiodarone 12 months prior to enrollment
History of AF ablation within 30 days prior to enrollment
Renal impairment (eGFR \< 30 mL/min/1.73 m2 or Serum Creatinine \> 1.25 mg/dL) for subjects over the age of 65
Hepatic disease (ALT/AST 2X the upper normal limit)
History of alcohol abuse and/or drug abuse per PI discretion
Pre-existing auditory damage
History of epilepsy
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)
Current participation in another clinical study
Serious or active medical or psychiatric condition which, in the opinion of the investigator, may interfere with treatment, assessment, or compliance with the protocol
Not able to discontinue medications known to have significant interactions with chloroquine

Interventions

DRUGChloroquine 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.