Monitoring Medication Adherence in Left Ventricular Assist Device Recipients

November 6, 2020 updated by: Scripps Translational Science Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • Scripps Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PROTEUS-SENSOR
The current study is a prospective interventional design with a single experimental arm. The intervention consists of two components: an edible sensor and a wearable receiver health monitor.
Device: PROTEUS-SENSOR
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes after ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Safety as measured by vital signs
  2. Cardiac rhythm monitoring review for arrhythmias
  3. LVAD device interrogation for changes in device parameters
  4. Implantable cardioverter defibrillator interrogation for arrhythmia occurrence
From time of ingestion to 30 minutes after ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Collaborators

Scripps Clinic

Investigators

  • Principal Investigator: Sanjeev Bhavnani, MD, Scripps Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROTEUS-LVAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available upon request

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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