What side effects are associated with this type of intervention?

Treatments for Torsades de Pointes often involve magnesium sulfate, which can cause side effects like hypotension, flushing, and bradycardia. Antiarrhythmic drugs such as lidocaine or isoproterenol may also be used, with potential side effects including dizziness, nausea, and arrhythmias. Continuous cardiac monitoring is essential to manage these treatments and monitor for adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Torsades de Pointes, primarily focusing on medications such as magnesium sulfate, which is the first-line treatment. Other antiarrhythmic drugs like lidocaine and isoproterenol may also be used in specific cases. Continuous cardiac monitoring systems, such as the Continuous Patch Monitoring System being studied, are crucial for early detection and management of arrhythmias, including Torsades de Pointes. These systems provide real-time data, allowing for timely intervention and potentially improving patient outcomes.

What other types of research exist?

Promising novel alternatives to Continuous Patch Monitoring System for Torsades de Pointes patients include external telemetry systems such as PhysioJacket and JET, as well as the KardiaMobile 6L, a six-lead contactless mobile ECG.

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Cardiac Monitoring Device

Continuous Cardiac Monitoring for Heart Arrhythmia (CARING Trial)

N/A

Recruiting

Led By Joshua D Mitchell, M.D., FACC

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through day 30

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a small, wearable patch that continuously monitors heart activity. It focuses on patients taking medications that could lead to heart problems. The goal is to see if this patch is as effective as standard heart monitoring methods like electrocardiograms (ECGs).

Who is the study for?

This trial is for adults over 18 with acute promyelocytic leukemia starting arsenic trioxide treatment, or those with solid tumors beginning capecitabine. Participants must not be allergic to adhesive patches and should be able to understand and sign a consent form.

What is being tested?

The study is testing the BodyGuardian Mini Plus, a continuous patch monitoring system for cardiac arrhythmias, against standard ECGs in patients taking drugs that may affect the heart.

What are the potential side effects?

Potential side effects are likely related to skin irritation due to the adhesive on the BodyGuardian Mini Plus patch. There might also be discomfort from wearing the device continuously.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot

Frequency of major arrhythmia occurrence

Trajectories of QT prolongation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Continuous patch monitoring systemExperimental Treatment1 Intervention

-Participants will receive standard of care treatment with either arsenic trioxide, ribociclib, or capecitabine. They will have continuous patch monitor system (BodyGuardian Mini Plus) applied on or prior to the first day of therapy and will receive at least 5 ECGs for comparison during the first 30 days of treatment.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Torsades de Pointes (TdP) include magnesium sulfate, which stabilizes the cardiac membrane and reduces early afterdepolarizations, and beta-blockers, which manage sympathetic overactivity. Discontinuation of QT-prolonging drugs is also critical. Continuous cardiac monitoring systems are vital for early detection and management of TdP, enabling timely interventions and reducing the risk of sudden cardiac death.

Clinical implications from the European Heart Rhythm Association consensus document on antiarrhythmic drug therapy.