More than 5 million individuals in the United States have clinically manifest Heart Failure (HF), and that number continues to rise with the country's aging population contributing to serious strains on the healthcare system and to huge economic costs. Diagnosing and managing the cardiovascular health concerns for such a large population, particularly the elderly who often also suffer from diabetes, has created a growing need for new healthcare paradigms that will help: (1) accommodate the physical challenges of aging and diabetic HF patients and (2) lower medical cost and the strain on healthcare resources. Elevated levels of natriuretic peptide biomarkers NT-proBNP and BNP indicate the presence of myocardial stress, and in people with HF, these have been shown to correlate with acute exacerbations of this condition. Quantitation of natriuretic peptide levels is critical to the determination of appropriate emergency and clinical treatment, and currently is the only blood-based assay that exists for the diagnosis of myocardial stress and management of HF. Studies where natriuretic peptides were used to guide drug therapies and diagnostics suggest reduced mortality and a significantly lowered number and duration of hospital stays. The goal of this project is development of a home-use sensing system that will allow HF patients to monitor their level of NT-proBNP at home, in much the same way that diabetics monitor their blood glucose levels. The project builds on extensive preliminary research that has resulted in a pre-prototype sensor design. At this very early stage in its development, the sensor is able to detect NT-proBNP at levels near the range of clinical utility in buffer at the lab bench. In the present proposal an ambitious plan is described to develop the sensor further and also to develop detailed plans for incorporating it into a complete monitoring system. The quantitative result of the NT- proBNP test would be available, via wireless technology, to the patient's cardiologist who may then remotely adjust the patient's medications. Importantly, the goal of the work is to monitor patients who have already been diagnosed with HF; that is, it is not intended as a diagnostic tool, but rather a patient care tool to help guide appropriate therapy and create better outcomes.
The specific aims i nclude development of a sensor platform capable of detecting NT-proBNP in whole human blood over a dynamic range appropriate for NYHA class I-III HF patients. In collaboration with a cardiologist, the sensor will be tested using blood from actual HF patients, and the resulting statistics will be compared to those obtained using a gold-standard method. Finally, working with world-class consultants, plans will be developed for a system design that incorporates the regulatory impacts and a health economics analysis to identify the routes to reimbursement. The opportunity to improve clinical decision-making, especially in relation to hospitalization and return to the community, directly addresses the NIH mission to improve quality of care, reduce costs, and more closely couple physiological changes to medical intervention.
Managing the cardiovascular health for a growing population of patients in the United States, particularly the elderly and those who also suffer from diabetes, has created a growing need for new technologies and processes to help: (1) alleviate stretched healthcare resources, (2) accommodate the physical challenges that these patients face, and (3) improve patient's quality of life. The proposed research aims to adapt a novel sandwich antibody detection assay for NT-proBNP (an accepted and physiologically robust biomarker for heart failure) to an inexpensive in-home test, the results of which can then be transmitted to the individual's physician for patient care management and planning. In-home monitoring of cardiovascular health stands the chance of making a real impact on patient quality of life by providing timely, individualized, pharmacologic care, decreasing the number of ER visits patients must endure, and diminishing the financial strain such visits impose on these patients and on the healthcare system.!
