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

NCT02932007 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Chloroquine AF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

persistent

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with termination of AF

  Within 2 weeks of study drug initiation

Secondary Outcomes (6)

• Percentage of AF burden

  Within 2 weeks of study drug initiation

• QT intervals

  Within 2 weeks of study drug initiation

• Time to AF termination

  Within 2 weeks of study drug initiation

• Percentages of classifications of rhythms identified

  Within 2 weeks of study drug initiation

• PR interval

  Within 2 weeks of study drug initiation

Study Arms (1)

Chloroquine Phosphate

EXPERIMENTAL

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

Interventions

Chloroquine Phosphate DRUG

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.

Chloroquine Phosphate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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, 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 \< 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 26960034 BACKGROUND

• 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.

  PMID: 26826133 RESULT

• 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.

  PMID: 22467674 RESULT

• 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.

  PMID: 26964092 RESULT

• 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.

  PMID: 20585026 RESULT

• 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.

  PMID: 13541664 RESULT

• 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.

  PMID: 2460205 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

chloroquine diphosphate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sami Noujaim, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanh Tran, MPH

CONTACT

813-844-8544; thanhtran@health.usf.edu

Sami Noujaim, PhD

CONTACT

813-974-6416; snoujaim@health.usf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 13, 2016
• Study Start: March 28, 2017
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 19, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)