Incardia Inc. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

ABSTRACT The objective of this study is to prove the feasibility of an innovative diagnostic device for the detection and monitoring of worsening heart failure. Heart failure affects 6.5 million of Americans and cost the US over $30B a year in healthcare services, medications and missed work. These costs are expected to double by 2030. Heart failure is associated with high healthcare utilization due to frequent hospital re-admissions. Heart failure is the most common diagnosis in all hospital admissions in patients over 65. The readmission rate is high – over 20% by 30 days, and 30% by 90 days post-discharge. There is a significant need for in-home non-invasive methods to detect early stages of destabilization in heart failure. Hemodynamic congestion defined as increasing filling pressures in the heart typically precedes other clinical symptoms. Detection and monitoring of hemodynamic congestion offers the healthcare professionals an opportunity to intervene by adjusting the medications and to prevent acute heart failure episodes and hospitalizations. This pilot clinical research study is designed to demonstrate that the innovative CorWatch™ technology is effective in detecting hemodynamic congestion in heart failure. CorWatch™ detects increases in central venous and right atrial pressures which are concordant with increase in the left heart filling pressures. Adult heart failure patients undergoing cardiac catheterization in a cardiac lab will be recruited for this study. The specific aims are to further develop CorWatch™ devices for the clinical trial; and to demonstrate a good agreement between the CorWatch™ technology and the cardiac pressures measured with the gold standard – Swan Ganz catheter. If this research study shows the effectiveness of the proposed diagnostic approach, CorWatch™ device can potentially be integrated into clinical practice of cardiologists and other physicians as an easy-to-use in-home non-invasive device for monitoring of heart failure. CorWatch™ will offer early warnings of worsening heart failure and aid healthcare professionals in prevention of patient’s destabilization that can lead to acute heart failure episode and hospitalization. Therefore, CorWatch™ has a potential to reduce the healthcare costs and to improve quality of life of heart failure patients.PROJECT NARRATIVE Millions of people in the US suffer from heart failure – a chronic progressive condition in which the heart muscle becomes too weak to meet the body’s needs. The patients frequently experience heart failure episodes and get re-admitted to hospitals. Easy-to-use non-invasive methods are needed to detect worsening heart failure and to reduce the number of hospital re-admissions. This research study aims to show that CorWatch™ device is effective in detecting the rising pressures in the heart - the early symptom of worsening heart failure. CorWatch™ can provide the healthcare professionals with early warnings and aid in improving the quality of life of the patients and in reducing the healthcare expenditures associated with hospital re-admissions due to heart failure.