Using chloroquine to treat persistent atrial fibrillation
Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study
PHASE2 · University of South Florida · NCT02932007
This study is testing if chloroquine can help people with persistent atrial fibrillation get back to a normal heart rhythm within two weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of South Florida (other) |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT02932007 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of chloroquine in terminating persistent atrial fibrillation (AF) within two weeks of treatment. It is an open-label study where participants will receive chloroquine phosphate and be monitored for their response to the medication. The study will assess chloroquine's potential as a pharmacological agent for cardioversion in patients with symptomatic persistent AF. Participants will be followed for two weeks after starting the drug to determine its efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a documented history of symptomatic persistent atrial fibrillation.
Not a fit: Patients who do not have persistent atrial fibrillation or those who are not currently on anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new pharmacological option for patients suffering from persistent atrial fibrillation.
How similar studies have performed: While the use of chloroquine for this specific purpose is novel, other studies have explored pharmacological approaches to managing atrial fibrillation with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampa, Florida
- University of South Florida — Tampa, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Sami Noujaim, PhD — University of South Florida
- Study coordinator: Thanh Tran, MPH
- Email: thanhtran@health.usf.edu
- Phone: 813-844-8544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, persistent