NCT02932007 · University of South Florida
Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study
What this study is about
The goal of this pilot study is to explore the effectiveness of chloroquine in terminating persistent AF and assess its potential role as a pharmacological cardioversion agent for the management of AF.
View original scientific description
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.
Interventions
DRUG
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.
Primary outcome measures
Proportion of patients with termination of AF
Time frame: Within 2 weeks of study drug initiation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Tampa, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2019 · Source of record for eligibility and locations