Assessing the Utility of Submaximal Cardiopulmonary Exercise Testing in Diagnosis and Treatment Management of Pulmonary Arterial Hypertension

评估次最大心肺运动试验在肺动脉高压诊断和治疗管理中的效用

• 批准号: 10482044
• 负责人: Dean Judson MacCarter
• 金额: $ 122.37万
• 依托单位: SHAPE MEDICAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10482044
• 关键词: Activities of Daily Living; Adoption; Adult; Blood Vessels; Cardiac Catheterization Procedures; Cardiopulmonary; Categories; Characteristics; Clinical; Clinical assessments; Communities; Community Practice; Computer software; Data; Detection; Diagnosis; Diagnostic Specificity; Disease; Disease Progression; Dyspnea; Early Diagnosis; Echocardiography; Exercise; Exercise Test; Exhibits; Gases; Gatekeeping; Goals; Intervention; Lung; Measures; Monitor; Morbidity - disease rate; Newly Diagnosed; Outcome Measure; Patients; Pattern Recognition; Pharmacologic Substance; Pharmacotherapy; Physiological; Pulmonary Gas Exchange; Pulmonary Hypertension; Reproducibility; Research; Rest; Right Ventricular Dysfunction; Sensitivity and Specificity; Severities; Severity of illness; Shapes; Small Business Innovation Research Grant; Standardization; Symptoms; System; Testing; Time; Treatment Efficacy; Ventricular; Walking; accurate diagnosis; adverse outcome; clinical care; clinically significant; cost; diagnostic accuracy; disease prognosis; evidence base; exercise capacity; exercise intolerance; hemodynamics; high risk; improved; mortality; patient response; prognostic significance; pulmonary arterial hypertension; pulmonary arterial pressure; response; right ventricular failure; screening; standard measure; standard of care; symptomatic improvement; tool; treatment response

Abstract Pulmonary hypertension (PH) is a devastating disease characterized by progressive dyspnea/exercise intolerance, right-heart failure, and carries a high risk of morbidity and early mortality. PH disease progression can be rapid, and any delay in the diagnosis and treatment of PH likely reduces survival. Given its clinical and prognostic significance, early and accurate diagnosis of PH to allow prompt and optimal establishment of clinical care is of critical importance. While traditional maximal/comprehensive cardiopulmonary exercise testing (CPET) has been validated in PH, it has limitations that have hindered its applicability to routine clinical assessment and monitoring. Our preliminary data suggest that the signature ventilatory and pulmonary gas exchange derangements of PH become apparent during even submaximal exercise. Our comprehensive proof-of-concept study (133 patients) supports our hypothesis that the addition of pulmonary gas exchange responses to a standardized 3-minute submaximal exercise test (Shape iCPET) to standard echocardiographic evidence of PH (i.e. RVSP >50 mmHg, suspicion of RV dysfunction) improves the sensitivity for PH detection by almost 40%. The Shape iCPET system is compact and utilizes pattern-recognition software that automates interpretation, making the system ideally suitable for widespread adoption. The overarching objective of this SBIR proposal is to categorically establish the Shape iCPET as a tool that: 1) improves early detection of PH; and 2) provides an objective evidence-based measure of PH therapy efficacy that can be easily used in academic and community practices. We have established a 10-center consortium of academic and community PH centers for this SBIR proposal. Specific Aim 1 will assess the clinical utility of submaximal cardiopulmonary exercise testing as a complementary tool for the identification of pulmonary hypertension. Specific Aim 2 will assess whether pharmacotherapy-induced improvements in pulmonary hypertension severity and disease status are reflected in the physiological responses to a standardized submaximal cardiopulmonary exercise test. We hypothesize that the Shape iCPET will prove to be an efficacious adjunct to traditional clinical metrics to track changes in pulmonary vascular function over time and responses to therapy aimed at alleviating PAH.

摘要 肺动脉高压(PH)是一种以进行性呼吸困难/运动为特征的破坏性疾病 不耐受，右心衰竭，发病率和早期死亡的风险很高。PH疾病进展 可以是快速的，而且在诊断和治疗上的任何延误都可能降低存活率。考虑到它的临床和 PH的预后意义、早期和准确的诊断，以便及时和最佳地建立 临床护理是至关重要的。而传统的最大/综合心肺锻炼 测试(CPET)已在PH中得到验证，但其局限性阻碍了其在常规临床上的适用性 评估和监测。我们的初步数据显示，特征呼吸机和肺气肿 甚至在次极量运动中，PH的交换紊乱也会变得明显。我们全面的 一项概念验证研究(133名患者)支持我们的假设，即肺内气体交换的增加 标准超声心动图对标准化3分钟次极量运动试验(Shape ICPET)的反应 PH的证据(即RVSP和GT；50 mmHg，怀疑RV功能障碍)提高了PH检测的敏感度 增加了近40%。Shape iCPET系统结构紧凑，并利用自动模式识别软件 解释，使该系统非常适合广泛采用。这样做的首要目标是 SBIR的建议是明确地将iCPET的形状确立为一种工具：1)早期改进 PH的检测；以及2)提供了PH治疗疗效的客观循证测量，该测量可以 易于在学术和社区实践中使用。我们已经建立了一个由10个中心组成的学术联盟 和社区公共卫生中心为这项SBIR提案。特定目标1将评估其临床应用 次极量心肺运动试验作为诊断冠心病的辅助工具 肺动脉高压。特定目标2将评估药物治疗是否导致 肺动脉高压严重程度和疾病状态的改善反映在生理上 对标准化次极量心肺运动试验的反应。我们假设这个形状 ICPET将被证明是传统临床指标的有效补充，以跟踪肺组织的变化 血管功能随时间的变化以及对旨在缓解PAH的治疗的反应。