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

Sponsor
University of South Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT02932007
Collaborator
(none)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chloroquine Phosphate
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study
Actual Study Start Date :
Mar 28, 2017
Anticipated Primary Completion Date :
Mar 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients with termination of AF [Within 2 weeks of study drug initiation]

Secondary Outcome Measures

  1. Percentage of AF burden [Within 2 weeks of study drug initiation]

    AF burden reported on pacemaker/ICD interrogation or 2-week Holter reports from baseline and 2 weeks post drug initiation

  2. QT intervals [Within 2 weeks of study drug initiation]

    From baseline, pre-treatment ECG compared to 2 weeks post treatment ECG

  3. Time to AF termination [Within 2 weeks of study drug initiation]

    In days on pacemaker/ICD interrogation or Holter reports obtained at 2 weeks after study drug initiation

  4. Percentages of classifications of rhythms identified [Within 2 weeks of study drug initiation]

    From pacemaker/ICD interrogation or Holter reports obtained at 2 weeks after study drug initiation

  5. PR interval [Within 2 weeks of study drug initiation]

    From baseline, pre-treatment ECG compared to 2 weeks post treatment ECG

  6. QRS duration [Within 2 weeks of study drug initiation]

    From baseline, pre-treatment ECG compared to 2 weeks post treatment ECG

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  1. Current participation in another clinical study

  2. Serious or active medical or psychiatric condition which, in the opinion of the investigator, may interfere with treatment, assessment, or compliance with the protocol

  3. Not able to discontinue medications known to have significant interactions with chloroquine

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Florida Tampa Florida United States 33606

Sponsors and Collaborators

  • University of South Florida

Investigators

  • Principal Investigator: Sami Noujaim, PhD, University of South Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of South Florida
ClinicalTrials.gov Identifier:
NCT02932007
Other Study ID Numbers:
  • Chloroquine AF
First Posted:
Oct 13, 2016
Last Update Posted:
Aug 19, 2019
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by University of South Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2019