09/04/2020
Ventricular Arrhythmia Risk Due to Hydroxychloroquine-Azithromycin Treatment For COVID-19:
Key points from ACC:
Safety considerations for inpatient and outpatient use of hydroxychloroquine and chloroquine in clinical practice are outlined below.
Hydroxychloroquine or chloroquine therapy should occur in the context of a clinical trial or registry, until sufficient evidence is available for use in clinical practice.
Hydroxychloroquine or chloroquine use outside of a clinical trial should occur at the direction of an infectious disease or COVID-19 expert, with cardiology input regarding QT monitoring.
Additional sources of expert guidance with detailed and general arrhythmia monitoring considerations are also available.
The intensity of QT and arrhythmia monitoring should be considered in the context of potential drug benefit, drug safety, resource availability and quarantine considerations.
IRB-approved protocols should guide use of hydroxychloroquine or chloroquine for pandemic research; suggestions for researchers are outlined here.
Suggested Protocol Elements For Clinical Research Monitoring
To inform understanding of the potential efficacy and safety of hydroxychloroquine
-azithromycin, we strongly advocate for enrollment of all patients who are candidates into IRB-approved clinical research protocols.
In balancing the importance of evaluating a therapeutic option where no effective therapies exist, while maximizing the safe use of QT prolonging medications in the research setting, we suggest protocols address the following:
Pre-enrollment
a. Discontinue and avoid all other non-critical
QT prolonging agents.
b. Assess baseline ECG
and renal function, hepatic function, serum
potassium and serum magnesium.
c. When possible, have an experienced
cardiologist/electrophysiologist measure
QTc, and seek pharmacist input in the
setting of acute renal or hepatic failure.
d. Assess baseline risk of QT prolongation
using the risk score of Tisdale et al.
Enrollment
Establish contraindications to study enrollment due to excessive risk of drug proarrhythmia. Potential absolute or relative contraindications for hydroxychloroquine-azithromycin combination use in clinical research include:
i Known congenital long QT syndrome
ii For inpatients:
Baseline QTc >500 msec (or >530-550 msec if QRS >120 msec),
or
Tisdale risk ≥11 + inability to monitor with serial ECGs or telemetry
iii For outpatients:
Baseline QTc >480 msec (or >510-530 msec if QRS >120 msec),
or
Tisdale risk ≥11
Ongoing monitoring, dose adjustment and drug discontinuation
a. Monitor and optimize serum potassium and
magnesium.
b. Monitor use of medications that may
precipitate electrolyte shifts, such as loop
and thiazide diuretics.
c. Prescribe a plan for continuous cardiac
telemetry and/or interval ECGs for QTc
monitoring, with provisions for
well-resourced and poorly-resourced
enrollment sites.
d. Discontinue therapy for observed
polymorphic ventricular tachycardia
or syncope with concern for arrhythmic
etiology.
e. Prescribe a dose reduction strategy for
patients who experience QT prolongation
with therapy (QTc >500 msec with normal
QRS; >530-550 msec
if QRS >120 msec; or increase in QTc >30-60
msec after initiation of treatment).
Reference :
https://www.acc.org/latest-in-cardiology/articles/2020/03/27/14/00/ventricular-arrhythmia-risk-due-to-hydroxychloroquine-azithromycin-treatment-for-covid-19
https://www.acc.org/latest-in-cardiology/articles/2020/03/27/14/00/ventricular-arrhythmia-risk-due-to-hydroxychloroquine-azithromycin-treatment-for-covid-19/new-folder/suggested-protocol-elements-for-clinical-research-monitoring
To inform understanding of the potential efficacy and safety of hydroxychloroquine-azithromycin, we strongly advocate for enrollment of all patients who are candidates into IRB-approved clinical research protocols.
