NCT02932007RecruitingPhase 2
Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study
Source: ClinicalTrials.gov · Last updated 19 Aug 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 7 Oct 2016
- Start date
- 28 Mar 2017
- Primary completion date
- 31 Mar 2020
- Lead sponsor
- University of South Florida
- Diseases
- Atrial fibrillation
- NCT number
- NCT02932007
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 28 Mar 2017 to the primary completion date, 31 Mar 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of amiodarone 12 months prior to enrollment
- History of AF ablation within 30 days prior to enrollment
- 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)
- Not able to discontinue medications known to have significant interactions with chloroquine
Other illness
- 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
- Known allergy or hypersensitivity to Chloroquine
- History of alcohol abuse and/or drug abuse per PI discretion
- History of epilepsy
- Serious or active medical or psychiatric condition which, in the opinion of the investigator, may interfere with treatment, assessment, or compliance with the protocol
Lab values
- Ejection fraction \< 50% within 1 year of consent
- Prolonged QTc of \>460 msec on baseline ECG
- 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)
Age
- Age \< 18 years
Other
- Severe or moderate to severe aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation per PI discretion
- Contraindications to quinolines
- Pre-existing auditory damage
- Current participation in another clinical study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.