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Chloroquine for Symptomatic Persistent and Longstanding Persistent AF

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ClinicalTrials.gov Identifier: NCT02932007
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
The goal of this pilot study is to explore the efficacy of chloroquine in terminating persistent and longstanding persistent AF and assess its potential role as a pharmacological cardioversion agent for the management of AF.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Chloroquine Phosphate Phase 2

Detailed Description:
This is an open-label, pilot study to explore the efficacy of chloroquine in terminating persistent and longstanding 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chloroquine for Patients With Symptomatic Persistent and Longstanding Persistent Atrial Fibrillation: A Prospective Pilot Study
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019


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.




Primary Outcome Measures :
  1. Proportion of patients with termination of AF [ Time Frame: Within 2 weeks of study drug initiation ]

Secondary Outcome Measures :
  1. Percentage of AF burden [ Time Frame: 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 [ Time Frame: Within 2 weeks of study drug initiation ]
    From baseline, pre-treatment ECG compared to 2 weeks post treatment ECG

  3. Time to AF termination [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Within 2 weeks of study drug initiation ]
    From baseline, pre-treatment ECG compared to 2 weeks post treatment ECG

  6. QRS duration [ Time Frame: Within 2 weeks of study drug initiation ]
    From baseline, pre-treatment ECG compared to 2 weeks post treatment ECG



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Eligibility for treatment with chloroquine according to local label
  • History of symptomatic persistent or longstanding 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 Longstanding persistent AF - defined as continuous AF of > 12 months and ≤ 3years of duration
  • AF must be documented at least once either by ECG, Holter monitoring, loop recorder, telemetry, trans-telephonic monitoring, pacemaker or cardiac defibrillator readouts within 24 months prior to enrollment
  • 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 or willingness to wear a 2 weeks Holter monitor if does not have an implanted pacemaker/ICD
  • Signed informed consent

Exclusion Criteria:

  • Age < 18 years
  • History of paroxysmal AF Paroxysmal AF - defined as recurrent AF (≥ 2 episodes) that terminates spontaneously within 7 days. Episodes of AF of ≤ 48 hours duration terminated with electrical or pharmacological cardioversion will also be classified as paroxysmal AF
  • Permanent AF Permanent AF - defined as ongoing AF > 3 years of duration
  • 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
  • Coronary heart disease
  • Left ventricular dysfunction with ejection fraction < 50%
  • Prolonged QTc of >440 msec on baseline ECG
  • Contraindications to quinolines
  • Known allergy to chloroquine
  • Use of amiodarone 12 months prior to enrollment
  • History of AF ablation within 30 days prior to enrollment
  • Renal failure requiring dialysis
  • Significant intrinsic liver disease
  • History of alcohol abuse
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932007


Contacts
Contact: Thanh Tran, MPH 813-844-8544 thanhtran@health.usf.edu
Contact: Sami Noujaim, PhD 813-974-6416 snoujaim@health.usf.edu

Locations
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Nhi Tran, MS    813-259-0628    nntran@health.usf.edu   
Principal Investigator: Sami Noujaim, PhD         
Sub-Investigator: Bengt Herweg, MD         
Sub-Investigator: Dany Sayad, MD         
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Sami Noujaim, PhD University of South Florida

Publications of Results:

Other Publications:
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02932007     History of Changes
Other Study ID Numbers: Chloroquine AF
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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:
persistent
longstanding persistent

Additional relevant MeSH terms:
Chloroquine
Chloroquine diphosphate
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics