Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

Completed · Not applicable

Conditions studied: Heart Failure, Medication Compliance

In brief

The investigators aim to develop a novel and wireless method for monitoring medication adherence among heart failure patients with left ventricular assist devices (LVADs). Proteus Digital™ has developed an ingestible and bio-absorbable micro-sensor as a strategy to monitor medication compliance. The edible sensor has at its core a silicon-based integrated circuit measuring 1.0 mm x 0.45 mm and is imbedded on a pill. Once ingested, this circuit is activated by gastric acid resulting in an electrochemical redox reaction and an electrical charge that is transmitted to a patch worn over the abdomen and wirelessly to a portable device such as a smart phone. This strategy of medication adherence differs from conventional adherence monitoring including pill counting and patient-recall by precisely tracking medication ingestion.

Key facts

Study ID

NCT02388386

Run by

Scripps Translational Science Institute

People needed

10

Starts

2015-02-01

Expected to finish

2016-04-01

Last updated by the study team

2020-11-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing LVAD implantation for end-stage heart failure or admitted from the out-patient setting

You may not qualify if…

• Unable to consistently consume oral intake
• Hemodynamic instability defined as hypotension requiring intravenous vasoactive medications or arrhythmias requiring intravenous antiarrhythmics or oral antiarrhythmics for rhythm stabilization
• Gastrointestinal bleeding requiring intravenous gastric acid secretion inhibitors

Where it is running

• Scripps Health — San Diego, California, United States

Full record on ClinicalTrials.gov

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