N/A
Completed N=10
Monitoring Medication Adherence in Left Ventricular Assist Device Recipients
Heart Failure · Medication Compliance
Source: ClinicalTrials.gov NCT02388386 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: System Performance - Positive Detection Accuracy — 80 percentage of ingestions
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.
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 | — |
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
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. Informational only — not medical advice.