A novel non-invasive device for screening and optimized management to improve heart failure outcomes in patients with diabetes mellitus

一种新型非侵入性设备，用于筛查和优化管理，以改善糖尿病患者的心力衰竭结果

• 批准号: 10274732
• 负责人: Kaustubh Kale
• 金额: $ 150万
• 依托单位: AVENTUSOFT, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-15 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10274732
• 关键词: Algorithms; Arrhythmia; Biological; Blood Pressure; Blood Tests; Businesses; Cardiac; Cardiac Catheterization Procedures; Cardiology; Cardiomyopathies; Cardiovascular Diseases; Cardiovascular system; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Congestive Heart Failure; Continuity of Patient Care; Control Groups; Coronary heart disease; Data; Development; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Diastolic heart failure; EFRAC; Early Diagnosis; Echocardiography; Endocrine; Endocrinologist; Endocrinology; Etiology; Evaluation; Event; FDA approved; Florida; Functional disorder; Goals; Gold; Health Fairs; Health Professional; Heart Atrium; Heart failure; Hospitalization; Image; Incidence; Institutional Review Boards; Lead; Left; Left Ventricular Dysfunction; Left Ventricular Mass; Measurement; Measures; Medical; Medical Device; Methods; Microvascular Dysfunction; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multi-site clinical study; Myocardial; Newly Diagnosed; Outcome; Participant; Pathway interactions; Patient Representative; Patients; Performance; Peripheral arterial disease; Pharmacotherapy; Phase; Prevalence; Prevention; Primary Care Physician; Primary Health Care; Public Health; Pulmonary artery structure; Randomized; Randomized Clinical Trials; Reporting; Risk; Risk Factors; Services; Severities; Single-Blind Study; Site; Small Business Innovation Research Grant; Specialist; Stroke; Structure; Technology; Testing; United States; Validation; Ventricular; Ventricular Dysfunction; Ventricular End-Diastolic Volumes; Visit; Work; base; checkup examination; clinical practice; commercialization; cost; detection method; diabetes management; diabetic; diabetic patient; economic impact; evidence base; follow-up; glycemic control; group intervention; health care quality; heart function; hemodynamics; improved; indexing; innovation; insight; macrovascular disease; meetings; mortality; novel; point of care; portability; pressure; primary outcome; prospective; recruit; screening; secondary outcome; standard of care; verification and validation; vibration; Algorithms; Arrhythmia; Biological; Blood Pressure; Blood Tests; Businesses; Cardiac; Cardiac Catheterization Procedures; Cardiology; Cardiomyopathies; Cardiovascular Diseases; Cardiovascular system; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Congestive Heart Failure; Continuity of Patient Care; Control Groups; Coronary heart disease; Data; Development; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Diastolic heart failure; EFRAC; Early Diagnosis; Echocardiography; Endocrine; Endocrinologist; Endocrinology; Etiology; Evaluation; Event; FDA approved; Florida; Functional disorder; Goals; Gold; Health Fairs; Health Professional; Heart Atrium; Heart failure; Hospitalization; Image; Incidence; Institutional Review Boards; Lead; Left; Left Ventricular Dysfunction; Left Ventricular Mass; Measurement; Measures; Medical; Medical Device; Methods; Microvascular Dysfunction; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multi-site clinical study; Myocardial; Newly Diagnosed; Outcome; Participant; Pathway interactions; Patient Representative; Patients; Performance; Peripheral arterial disease; Pharmacotherapy; Phase; Prevalence; Prevention; Primary Care Physician; Primary Health Care; Public Health; Pulmonary artery structure; Randomized; Randomized Clinical Trials; Reporting; Risk; Risk Factors; Services; Severities; Single-Blind Study; Site; Small Business Innovation Research Grant; Specialist; Stroke; Structure; Technology; Testing; United States; Validation; Ventricular; Ventricular Dysfunction; Ventricular End-Diastolic Volumes; Visit; Work; base; checkup examination; clinical practice; commercialization; cost; detection method; diabetes management; diabetic; diabetic patient; economic impact; evidence base; follow-up; glycemic control; group intervention; health care quality; heart function; hemodynamics; improved; indexing; innovation; insight; macrovascular disease; meetings; mortality; novel; point of care; portability; pressure; primary outcome; prospective; recruit; screening; secondary outcome; standard of care; verification and validation; vibration

7. PROJECT SUMMARY/ABSTRACT This SBIR Fast-Track project will develop a novel non-invasive device for left ventricular dysfunction assessment to improve heart failure outcomes in patients with diabetes, validated through a multi-center clinical trial to support FDA 510(k) clearance. According to national diabetes report, 33 million people in United States suffered from diabetes. Abundant evidence shows diabetes is major independent risk factor for several cardiovascular disorders including coronary heart disease, stroke, peripheral arterial disease, cardiomyopathy, and congestive heart failure (HF). Large, randomized clinical trials for screening and revascularization of stable macrovascular disease in diabetics, have failed to demonstrate a significant reduction in cardiac events and HF episodes. Studies have demonstrated that early detection of left ventricular dysfunction and prevention of microvascular complications through glycemic control in diabetes patients is a critical mechanism for reducing the incidence and severity of left ventricular dysfunction and HF. Thus, given the clinical and economic impact of diabetes and HF, and in view of the risk and cost of invasive monitoring there is a need for non-invasive, affordable, accurate, absolute and actionable method that can provide point-of-care left ventricular dysfunction assessment and facilitate optimized management of diabetes patients across the continuity of care. Towards this goal, Aventusoft has developed a novel non-invasive medical device (HEMOTAG) enabling specific measurements of left ventricular dysfunction, anywhere, anytime by anyone. Aventusoft has completed multiple Institutional Review Board approved clinical studies to demonstrate the major clinical advancement. Phase I and II activities will focus on larger multi-center clinical studies, enhancing the HEMOTAG technology for hemodynamic guided assessment and management to reduce rates of left ventricular systolic dysfunction, diastolic dysfunction, and improve HF outcomes in diabetes patients, reducing HF hospitalization, mortality, and morbidity. Resulting in FDA 510(k) indications of use, for HEMOTAG guided treatment for diabetes patients. The development of a non-invasive, accurate and easy-to-use solution to provide actionable targets measurements without requiring blood tests, echocardiogram imaging or right heart catheterization, will have great potential not only for HF management in diabetes but for many other etiologies as well. Communities across the globe lack access to quality healthcare arising from shortages in medical expertise and availability of medical diagnostic devices. The benefit of this pioneering work is the development of a low-cost and portable solution that 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 left ventricular dysfunction as routine as measuring blood pressure. HEMOTAG verification and validation would be completed during the Phase II. Followed by commercialization in Florida and nationwide, based on the business partnerships and clinical collaborations established to help create a commercially successful product.

7。项目摘要/摘要 这个SBIR快速轨道项目将开发出一种新型的非侵入性设备，用于左心室功能障碍 评估以改善糖尿病患者的心力衰竭结局，通过多中心验证 支持FDA 510（k）清除的临床试验。根据国家糖尿病的报告，联合的3,300万人 州患有糖尿病。大量证据表明，糖尿病是多个的主要独立危险因素 心血管疾病，包括冠心病，中风，外周动脉疾病，心肌病， 和充血性心力衰竭（HF）。大型，随机的临床试验，用于筛查和血运重建 糖尿病患者中的大血管疾病未能证明心脏事件的显着降低和 HF情节。研究表明，早期发现左心室功能障碍和预防 通过糖尿病患者的血糖控制微血管并发症是减少的关键机制 左心室功能障碍和HF的发生率和严重程度。因此，鉴于临床和经济影响 糖尿病和HF，以及侵入性监测的风险和成本，需要非侵入性， 负担得起，准确，绝对和可行的方法，可以提供左心室功能障碍的护理点 评估和促进对糖尿病患者的优化管理，跨护理的连续性。向 这个目标，Aventusoft开发了一种新型的非侵入性医疗设备（Shemotag），以实现特定 任何人随时随地对左心室功能障碍的测量。 Aventusoft已完成 多个机构审查委员会批准了临床研究，以证明主要的临床进步。 第一阶段和第二阶段的活动将集中在更大的多中心临床研究上 为了减少左心室收缩功能障碍率的血液动力学指导性评估和管理 舒张功能障碍并改善糖尿病患者的HF结局，降低HF住院，死亡率， 和发病率。导致FDA 510（k）使用指标，用于糖尿病的示血性治疗 患者。开发非侵入性，准确且易于使用的解决方案，以提供可行的目标 不需要血液检查，超声心动图成像或正确的心脏导管插入的测量，将具有 不仅对于糖尿病的HF管理，而且对于许多其他病因也很大。社区 全球缺乏由于医疗专业知识和可用性短缺而引起的优质医疗保健 医疗诊断设备。这项开创性工作的好处是开发低成本和 便携式解决方案，可在常规的年度检查，医生探访期间改进筛查，在社区 医疗检查，课程和健康展览会导致更健康的社区。它将使左测量 心室功能障碍是常规的，就像测量血压一样。 Shemotag验证和验证将 在第二阶段完成。其次是基于佛罗里达州和全国的商业化 建立了业务合作伙伴关系和临床合作，以帮助创建商业上成功的产品。