A single centre, open, non-controlled, observational, investigator initiated, data collection study to assess the feasibility of using an investigative non-invasive chest worn wearable device to assess congestion levels in heart failure patients

Heart failure is a major problem that drains the healthcare expenditure across the world and in India as well. The largest chunk of heart failure expense is due to repeated hospital admissions that becomes necessary in these patients. Most heart failure decompensation events that lead to hospital admissions are due to severe lung congestion and diuretics are the most commonly used therapy to manage congestion. Optimally titrating the diuretic dosage however, has been a major challenge due to the lack of reliable and simple tools to quantify the extent of congestion. This leads to either inadequate diuresis or excessive diuresis both of which result in poor prognosis, re-hospitalizations and increased mortality.

AnuSar Medequips private limited, a medical device startup company has developed a fully non-invasive, chest worn wearable patch device, which can provide the patient’s thoracic fluid status level continuously in real time. This observational study is intended to assess the possibility of using this device as a future tool to assess the congestion levels in heart failure patients while they are admitted in the hospital. Such an objective tool (instead of being subjective to the clinical judgement) can enable optimally titrating the diuretics and other medications to relieve congestion, which can lead to better clinical outcomes.

The intent of this clinical study on 30 patients admitted due to acute decompensation of heart failure, is to assess the feasibility of using a chest worn, battery powered, non-invasive wearable investigative device as a tool to assess the congestion status in heart failure patients. This would be a purely observational data collection study where data would be collected from the wearable device alongside other standard clinical parameters (CT scan, NTproBNP and Echocardiogram) used in clinical practice. No clinical decision would be made based on the device reported findings. No patient identifiable information would be entered or stored in the device application.

The primary endpoint of this study is to analyse the correlation of the device reported fluid score against lung fluid status derived from CT thorax scan. The secondary endpoint of this study is to analyse the correlation between device reported fluid score and NTproBNP value.