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Atrial FibrillationPhase 2NCT02932007

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

A Phase 2 study testing Chloroquine Phosphate in people with Atrial Fibrillation, run by University of South Florida at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Chloroquine Phosphate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
28 Mar 2017to Sep 2020
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thanh Tran, MPH contact

813-844-8544

thanhtran@health.usf.edu

Sami Noujaim, PhD contact

813-974-6416

snoujaim@health.usf.edu

United States1 site, 1 recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Nhi Tran, MS, 813-259-0628, nntran@health.usf.edu

    Jacob Siddoway, jsiddoway@health.usf.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Chloroquine Phosphate
Keywords
persistent
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chloroquine PhosphateDrug

    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.

Study groups in NCT02932007
Study groupRoleWhat they receive
Chloroquine PhosphateExperimentalChloroquine 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.
Receives: Drug: Chloroquine Phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with termination of AF

    Measured: Within 2 weeks of study drug initiation

Secondary outcomes (6)

  1. Percentage of AF burden

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

    Measured: Within 2 weeks of study drug initiation

  2. QT intervals

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

    Measured: Within 2 weeks of study drug initiation

  3. Time to AF termination

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

    Measured: Within 2 weeks of study drug initiation

  4. Percentages of classifications of rhythms identified

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

    Measured: Within 2 weeks of study drug initiation

  5. PR interval

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

    Measured: Within 2 weeks of study drug initiation

  6. QRS duration

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

    Measured: Within 2 weeks of study drug initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study start28 Mar 2017
  3. Primary completionMar 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02932007
Sponsor's protocol ID
Chloroquine AF
Status last verified
Oct 2018
First submitted
7 Oct 2016
Last updated
19 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nguyen T, Jolly U, Sidhu K, Yee R, Leong-Sit P. Atrial fibrillation management: evaluating rate vs rhythm control. Expert Rev Cardiovasc Ther. 2016 Jun;14(6):713-24. doi: 10.1586/14779072.2016.1164033. Epub 2016 Mar 30.

    PubMed 26960034

  • Boriani G, Laroche C, Diemberger I, Fantecchi E, Popescu MI, Rasmussen LH, Dan GA, Kalarus Z, Tavazzi L, Maggioni AP, Lip GY. 'Real-world' management and outcomes of patients with paroxysmal vs. non-paroxysmal atrial fibrillation in Europe: the EURObservational Research Programme-Atrial Fibrillation (EORP-AF) General Pilot Registry. Europace. 2016 May;18(5):648-57. doi: 10.1093/europace/euv390. Epub 2016 Jan 29.

    PubMed 26826133

  • Filgueiras-Rama D, Martins RP, Mironov S, Yamazaki M, Calvo CJ, Ennis SR, Bandaru K, Noujaim SF, Kalifa J, Berenfeld O, Jalife J. Chloroquine terminates stretch-induced atrial fibrillation more effectively than flecainide in the sheep heart. Circ Arrhythm Electrophysiol. 2012 Jun 1;5(3):561-70. doi: 10.1161/CIRCEP.111.966820. Epub 2012 Mar 30.

    PubMed 22467674

  • Lee YS, Hwang M, Song JS, Li C, Joung B, Sobie EA, Pak HN. The Contribution of Ionic Currents to Rate-Dependent Action Potential Duration and Pattern of Reentry in a Mathematical Model of Human Atrial Fibrillation. PLoS One. 2016 Mar 10;11(3):e0150779. doi: 10.1371/journal.pone.0150779. eCollection 2016.

    PubMed 26964092

  • Noujaim SF, Stuckey JA, Ponce-Balbuena D, Ferrer-Villada T, Lopez-Izquierdo A, Pandit S, Calvo CJ, Grzeda KR, Berenfeld O, Chapula JA, Jalife J. Specific residues of the cytoplasmic domains of cardiac inward rectifier potassium channels are effective antifibrillatory targets. FASEB J. 2010 Nov;24(11):4302-12. doi: 10.1096/fj.10-163246. Epub 2010 Jun 28.

    PubMed 20585026

  • BURRELL ZL Jr, MARTINEZ AC. Chloroquine and hydroxychloroquine in the treatment of cardiac arrhythmias. N Engl J Med. 1958 Apr 17;258(16):798-800. doi: 10.1056/NEJM195804172581608. No abstract available.

    PubMed 13541664

  • Harris L, Downar E, Shaikh NA, Chen T. Antiarrhythmic potential of chloroquine: new use for an old drug. Can J Cardiol. 1988 Sep;4(6):295-300.

    PubMed 2460205

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chloroquine Phosphate in people with Atrial Fibrillation, run by University of South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thanh Tran, MPH (813-844-8544, thanhtran@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with termination of AF (time frame: Within 2 weeks of study drug initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02932007, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.

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