Project Grant R44HL167296

A MOBILE HEALTH FRAMEWORK FOR LEFT VENTRICULAR END DIASTOLIC PRESSURE DIAGNOSTICS AND MONITORING. - PROJECT SUMMARY/ABSTRACT THIS SBIR FAST-TRACK PROJECT WILL DEVELOP A NOVEL MOBILE HEALTH FRAMEWORK FOR LEFT VENTRICULAR END DIASTOLIC PRESSURE DIAGNOSTICS AND MONITORING, USING AN INNOVATIVE, NON-INVASIVE CARDIAC BIOSENSOR. HEART DISEASE IS THE LEADING CAUSE OF DEATH FOR MEN AND WOMEN ACCOUNTING FOR MORE THAN ONE-THIRD (33.6%) OF ALL U.S. DEATHS. THE TOTAL COSTS ASSOCIATED WITH CARDIOVASCULAR DISEASE IN THE U.S. WERE ESTIMATED TO BE $363 BILLION, MAKING IT THE COSTLIEST HEALTH PROBLEM FACING THE NATION. IN ADDITION, IT OCCURS DISPROPORTIONATELY AMONG MINORITY AND HEALTH DISPARITY POPULATIONS. FOR EXAMPLE, HEART FAILURE RELATED DEATHS ARE 30% HIGHER AMONG AFRICAN-AMERICANS THAN AMONG NON-HISPANIC WHITES. LEFT VENTRICULAR END DIASTOLIC PRESSURE (LVEDP) IS A REFLECTION OF VENTRICULAR COMPLIANCE AND INTRAVASCULAR VOLUME AND PRESSURE; IT RELATES BOTH ACUTELY AND CHRONICALLY TO CLINICAL CONDITIONS THAT AFFECT VENTRICULAR PERFORMANCE. LVEDP IS ELEVATED IN THE SETTING OF HEART FAILURE (HF), AND ITS MEASUREMENT IS USED IN THE MANAGEMENT OF HF. OVERALL CARDIAC HEALTH CAN BE SIGNIFICANTLY IMPROVED BY PROPER TRIAGE AT THE PRIMARY CARE LEVEL BY DETERMINATION OF THE LVEDP WITHOUT REQUIRING A 2-D ECHO-CARDIOGRAM OR LEFT HEART CATHERIZATION. IT WILL PROVIDE HEALTH CARE PROFESSIONALS WITH TECHNOLOGY TO GUIDE DIAGNOSTIC AND FACILITATE EASY HOME-BASED MANAGEMENT BY PATIENTS. USING EVERYDAY SMARTPHONES MAKES IT EVEN MORE ACCESSIBLE AND READILY AVAILABLE WITHOUT ADDING HIGH COSTS. AS THE TECHNOLOGY BEING DEVELOPED DOES NOT REQUIRE SKILLED OPERATORS OR SPECIALLY TRAINED PHYSICIANS, IT WILL ALLOW HEALTHCARE PROVIDERS TO ASSESS LVEDP WITHIN THEIR NORMAL MEDICAL TRAINING. THROUGH THE COURSE OF THIS PROJECT WE WILL VALIDATE THIS REVOLUTIONARY MOBILE HEALTH FRAMEWORK THAT ENABLES MEASUREMENT OF LVEDP USING EVERYDAY SMARTPHONES. THE SCOPE OF THE SCIENCE PROPOSED IN THIS PROJECT IS TO COMPLETE DEVELOPMENT OF THE DIAGNOSTIC FRAMEWORK USING OUR SPECIALLY ENGINEERED SENSOR SYSTEM COMBINED WITH THE NOVEL ALGORITHM TECHNOLOGY TO BE ACCESSED VIA A SMARTPHONE FOR A PORTABLE AND COST- EFFECTIVE SOLUTION. RESOURCE-POOR COMMUNITIES ACROSS THE GLOBE LACK ACCESS TO QUALITY HEALTHCARE ARISING FROM SHORTAGES IN MEDICAL EXPERTISE AND POOR AVAILABILITY OF EXPENSIVE MEDICAL DIAGNOSTIC DEVICES. IN RECENT YEARS, MOBILE PHONES HAVE BECOME INCREASINGLY ADVANCED AND UBIQUITOUS. THE MOBILE FRAMEWORK DEVELOPED THROUGH THIS PROJECT IS A TREMENDOUS OPPORTUNITY TO PROVIDE LOW-COST DIAGNOSTICS TO UNDER-SERVED POPULATIONS. THE BENEFIT OF THIS PIONEERING WORK IS THE DEVELOPMENT OF AN EASY-TO-USE SOLUTION THAT CAN MEASURE VENTRICULAR COMPLIANCE, AND THUS ENABLE IMPROVED SCREENING DURING ROUTINE ANNUAL CHECKUPS, DOCTOR VISITS, AT COMMUNITY MEDICAL SCREENINGS, CLASSES, AND HEALTH FAIRS LEADING TO HEALTHIER COMMUNITIES. IT WILL MAKE MEASURING LVEDP AS ROUTINE AS MEASURING BLOOD PRESSURE. IN PHASE II, WE WILL CONTINUE VALIDATION OF THE DEVICE THROUGH USER- TRIALS AND SEEK FDA 510(K) CLEARANCE FOR COMMERCIALIZATION. FOLLOWED BY COMMERCIALIZATION IN THE FLORIDA AND NATIONWIDE, BASED ON THE PARTNERSHIPS AND JOINT COLLABORATIONS ESTABLISHED TO HELP CREATE A COMMERCIALLY SUCCESSFUL PRODUCT.