Sunday, December 11, 2011

Aventyn Announces Clinical Study

The Cleveland Clinic estimates between 500,000 and 900,000 new cases of heart failure are diagnosed each year in Medicare patients leading to 200,000 deaths and one million hospitalizations annually. Readmissions for heart failure patients occur at a rate of over 27% after the first 30 days of discharge with more than half of that percentage readmitted over the course of the next 180 days to 12 months with overall costs estimated at $20 billion.

A study announced at the recent 2011 mHealth Summit will help to more effectively manage heart failure. Aventyn® a provider of remote patient monitoring and chronic disease management solutions is conducting a Remote-HF-1 Mobile Heart Failure Clinical Study.

The study is geared to help heart failure patients use “Vitalbeat” a specially designed patient adherence and monitoring software available in standard mobile devices. The study is being sponsored at international heart centers in collaboration with BMS Hospital Trust in India, AT&T Healthcare, University of California, and Zephyr Technology.

This international multi-center study is uniquely positioned to assess different health systems and infrastructures across nations on three continents for the very first time. It is also the first study aimed at testing the feasibility of mobile device monitoring in a representative sample of at-risk patients that does not involve paper, telephone, or web based technology that uses mobile-based remote monitoring. The patient-entered data and vital signs captured from medically certified devices and biosensors are instantaneously available on the software monitored at the physician’s end.

A total of 65 patients have been recruited from five centers across three continents. The patients at each center have been provided with mobile smartphone devices activated by a local mobile service provider. Additionally, clinicians and study coordinators are able to use tablet computer monitoring that provides immediate access to the information. Automated blood pressure monitoring apparatus, weight scales, and Bioharness™ wearable monitors are being used by patients to send vital sign data along with diet, medication adherence, and activity levels to the monitoring clinician.

The primary objective for Phase1 is to evaluate the study in terms of reliability and to provide seamless data transmission. Principal Investigator Dr. Satish Govind, MD, PhD reports that Phase 2 to take place in 2012 will be an interventional trial with a significantly larger patient enrollment, use more sophisticated vital sign sensor devices, plus the next phase will use cloud data sharing to manage long term preventive and wellness programs.

For more information, contact Puja Chandler at +1.858.232.2698 or email