N/A N=10 Diagnostic

Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

Heart Failure · Medication Compliance

Bottom Line

View on ClinicalTrials.gov: NCT02388386 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: System Performance - Positive Detection Accuracy — 80 percentage of ingestions

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PROTEUS-SENSOR (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Scripps Translational Science Institute
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY System Performance - Positive Detection Accuracy	80	—
SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability	0; 0; 0; 0	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02388386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.