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New treatment option for Atrial Fibrillation
Official title Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study
ClinicalTrials.gov ID: NCT02932007
What this study is testing
What is Chloroquine Phosphate?
Chloroquine Phosphate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 must be documented at least once either by ECG, event monitoring, loop recorder, telemetry, trans-telephonic monitoring, pacemaker or cardiac...
- Currently on anticoagulation therapy as indicated per local guidelines, which is considered optimal for stroke prevention in the opinion of the...
- Implanted dual chamber pacemaker/ICD capable of monitoring atrial arrhythmias or willingness to wear a 2 weeks event monitor if patient does not have...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
- 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 \ 1.25 mg/dL) for people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.