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Completed

NCT Number: NCT02388386

Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Health Behavior Heart Diseases Medication Adherence Medication Compliance Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Health

San Diego, California, 92037, United States

About this study

The objectives are to assess the efficacy and safety of the Proteus Digital™ micro-sensor in an exploratory investigation among heart failure patients with LVADs. Medication adherence, specifically to anticoagulation is critically important in the post-implant period to maintain LVAD function and to decrease thromboembolic complications; however, commonly results in significant bleeding resulting in significant morbidity and mortality. In addition, the anticipated degree of anticoagulation is unpredictable after LVAD implantation due to factors related to changes in hepatic blood flow and endothelial dysfunction. Enrolling 10 patients will provide results into the function of micro-sensor and to provide a preliminary assessment of sensor-based activity, signal strength and signal duration in LVAD recipients. Participants will be enrolled during an in-patient hospitalization to assess the efficacy and safety of the device in a monitored setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROTEUS-SENSOR

Device

An edible sensor system, Proteus Digital™ has been developed for electronically confirming medication adherence, gathering physiologic metrics and communicating these data to patients. The system consists of two major components: an edible sensor and a wearable receiver health monitor. An electrical signal is activated upon ingestion of the Proteus Digital micro-sensor with transmission of this signal to a receiving abdominal patch to quantify medication compliance.

Primary outcomes

  1. System Performance - Positive Detection Accuracy

    Time frame: 30 minutes after ingestion

    Primary outcome measure of system performance will be estimated by the positive detection accuracy, defined as the number of ingestible sensors detected divided by those ingested

Secondary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: From time of ingestion to 30 minutes after ingestion

    Specific safety metrics will consist of the following composite outcome:

    • Safety as measured by vital signs
    • Cardiac rhythm monitoring review for arrhythmias
    • LVAD device interrogation for changes in device parameters
    • Implantable cardioverter defibrillator interrogation for arrhythmia occurrence

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Collaborators

  • Scripps Clinic

Registry information

Official study title

Pilot Study of Wireless Observed Therapy With an Ingestible Micro-Sensor Among Patients With Heart Failure and Left Ventricular Assist Devices

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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