Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-response in Patients With Heart Failure: A Randomized Controlled Trial

左束支区起搏作为心力衰竭患者心脏再同步治疗无反应的抢救策略的评估：随机对照试验

• 批准号: 10703634
• 负责人: Selma D Carlson
• 金额: --
• 依托单位: MINNEAPOLIS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10703634
• 关键词: Address; Adult; Affect; Area; Award; Biometry; Bundle-Branch Block; Bypass; Cardiac; Cardiac conduction system; Cardiac health; Cardiology; Caring; Categories; Cessation of life; Clinical; Data; Development; Devices; Diagnostic; Diagnostic Imaging; EFRAC; Echocardiography; Economic Burden; Evaluation; Future; Goals; Grant; Health Care Costs; Healthcare; Healthcare Systems; Heart; Heart Rate; Heart failure; Hospitalization; Image; Imaging Device; Institution; Interdisciplinary Study; Intervention; Intervention Trial; Investigation; K-Series Research Career Programs; Lead; Left; Left Ventricular Ejection Fraction; Left Ventricular Function; Left ventricular structure; Magnetic Resonance Imaging; Measurement; Measures; Mechanics; Mentors; Methods; Minnesota; Modality; Morbidity - disease rate; Morphologic artifacts; New York; Output; Pathologic; Patient-Focused Outcomes; Patients; Physiological; Population; Protocols documentation; Quality of Care; Quality of life; Randomized; Randomized, Controlled Trials; Reproducibility; Research; Research Activity; Research Personnel; Research Project Grants; Research Training; Right ventricular structure; Risk; Symptoms; System; Techniques; Therapeutic; Time; Tissues; Training; Uncertainty; Universities; Ventricular; Ventricular septum; Veterans; Veterans Health Administration; cardiac device; cardiac magnetic resonance imaging; cardiac pacing; cardiac resynchronization therapy; cardiac vein; career; clinical care; clinical center; cost; design; effectiveness evaluation; experience; experimental study; group intervention; heart function; heart imaging; hospitalization rates; implantable device; implementation science; improved; improved outcome; innovation; meetings; mortality; novel; patient oriented; patient population; patient response; pharmacologic; post intervention; prospective; randomized, controlled study; skills; standard care; sudden cardiac death; symptomatic improvement; training project; treatment group

Overview: I am reapplying for a 5-year Career Development Award (CDA) to support my overarching goal of studying how imaging tools can improving care of heart failure (HF) patients who require device therapy. This will be accomplished through the completion of mentored research activities and formal training designed to provide the skills necessary to become an independent investigator. During the course of my award, I will study an innovative method of cardiac resynchronization therapy (CRT) in patients with HF who have not had an improvement in cardiac function with the standard treatment of care. I also plan to establish the feasibility of cardiac MRI to assess cardiac function over time in patients with heart failure treated with device therapy. Significance: HF is one of the most common conditions cared for by the Veterans Health Administration and has a 15% annual mortality rate in VA patients. Approximately 50% of the hospitalizations for HF occur in patients with reduced ejection fraction (HFrEF). In these patients, a primary treatment goal includes strategies to increase the cardiac fraction, which has been shown to improve symptoms and decrease the risk of sudden cardiac death. In patients who also have a left bundle branch block, the main therapy has involved placing cardiac pacing leads in the right ventricle and in a cardiac vein overlying the left ventricle, referred to as CRT. However, up to 40% patients who undergo CRT fail to experience the expected improvement in cardiac function and symptoms after 6 months and are referred to as “non-responders.” This study aims to improve cardiac function in “non-responders” by pacing the heart from the left bundle branch area, thereby utilizing the heart’s intrinsic electrical system to promote coordinated ventricular contractions. The intervention developed in this CDA proposal has the potential for wide-reaching impact as it could significantly decrease the morbidity and mortality of HFrEF patients and reduce costs and burdens placed on the VA health care system. Career Plan: My primary area of research has focused on improving outcomes for patients with heart failure. To successfully achieve my goals of improving care for heart failure patients that require device therapy, I need further mentored training in implementation science including: quantitative and mixed methods training, expertise in diagnostic imaging training and research (particularly cardiac MRI), further biostatistics training, and cultivating multidisciplinary collaboration and networking skills. I will achieve these objectives through formal coursework, seminars, and mentored research activities under the guidance of primary mentors Selçuk Adabag, MD, MS (MVAHCS) and Chetan Shenoy, MBBS, MS (University of Minnesota Department of Cardiology), and secondary mentors Bradley Bart, MD (MVAHCS) and Sue Duval (University of Minnesota Department of Cardiology). The mentored research training through this grant will lay the groundwork for my long-term goal of becoming a recognized leader and researcher focused on the use of cardiac imaging to improve patient centered and clinical outcomes for patients with heart failure who require device therapy. Research Plan: My primary research objective is to assess a novel method of CRT in patient with HFrEF and LBBB, who have failed to respond to traditional CRT therapy. To execute this goal, I will complete the following: 1) a prospective, randomized-controlled study assessing the effectiveness of left bundle branch area pacing (LBBAP) vs continued CRT (the current gold standard) in improving cardiac function and patient symptoms, 2) assess the accuracy and feasibility of cardiac MRI in measuring cardiac function in patients with device therapy. The proposed training and research will generate preliminary data necessary for development of a future Merit award proposal to be submitted in Year 4. I plan to propose a prospective, multicenter, randomized controlled trial of the intervention evaluated in this study, which will launch my career as an independent VA CSR&D investigator committed to improving Veterans’ cardiac health though improved diagnostic and therapeutic treatment options.

概述：我正在重新申请5年职业发展奖（CDA），以支持我的总体目标， 研究成像工具如何改善需要器械治疗的心力衰竭（HF）患者的护理。这 将通过完成指导研究活动和正式培训来实现， 提供成为独立调查员所需的技能。在获奖期间，我将研究 心脏起搏治疗（CRT）的一种创新方法，用于未接受过心脏起搏治疗的HF患者， 通过标准治疗护理改善心脏功能。我还计划建立可行性， 心脏MRI用于评估接受器械治疗的心力衰竭患者随时间推移的心脏功能。 意义：HF是退伍军人健康管理局治疗的最常见疾病之一， VA患者的年死亡率为15%。大约50%的HF住院治疗发生在 射血分数降低（HFrEF）患者。在这些患者中，主要治疗目标包括策略 增加心脏分数，这已被证明可以改善症状并降低突发性心脏病的风险。 心源性死亡对于同时存在左束支分支传导阻滞的患者，主要的治疗方法是将 右心室和覆盖左心室的心脏静脉中的心脏起搏引线，称为CRT。 然而，高达40%的接受CRT的患者未能经历预期的心脏改善， 6个月后，患者的功能和症状消失，称为“无应答者”。本研究旨在提高 通过从左束支分支区域起搏心脏，从而利用 心脏的内在电系统，以促进协调心室收缩。干预发展 在这个CDA提案中，有可能产生广泛的影响，因为它可以显着降低发病率 和HFrEF患者的死亡率，并降低VA医疗保健系统的成本和负担。 职业规划：我的主要研究领域集中在改善心力衰竭患者的预后。 为了成功实现我的目标，改善需要器械治疗的心力衰竭患者的护理，我需要 在实施科学方面进一步开展指导培训，包括：定量和混合方法培训， 诊断成像培训和研究（特别是心脏MRI）的专业知识，进一步的生物统计学培训， 培养多学科协作和网络技能。我将通过以下方式实现这些目标： 正式的课程，研讨会，并指导下的主要导师Selçuk指导研究活动 Adabag，MD，MS（MVAHCS）和Chetan Shenoy，MBBS，MS（明尼苏达大学医学系 心脏病学），以及二级导师布拉德利巴特，医学博士（MVAHCS）和苏杜瓦尔（明尼苏达大学 心脏科）。通过这笔赠款进行的指导性研究培训将为我的研究奠定基础。 长期目标是成为公认的领导者和研究人员，专注于使用心脏成像， 改善需要器械治疗的心力衰竭患者的以患者为中心的临床结局。 研究计划：我的主要研究目标是评估HFrEF患者的CRT新方法， LBBB患者对传统CRT治疗无效。为了实现这一目标，我将完成 以下：1）一项前瞻性、随机对照研究，评估左束分支面积的有效性 起搏（LBBAP）与持续CRT（当前金标准）在改善心功能和患者 2）评估心脏MRI在测量心脏功能方面的准确性和可行性， 器械疗法拟议的培训和研究将产生发展所需的初步数据 未来的优异奖提案将在第四年提交。我计划提出一个前瞻性多中心， 在这项研究中评估的干预措施的随机对照试验，这将启动我的职业生涯， 独立的VA CSR&D调查员致力于改善退伍军人的心脏健康， 诊断和治疗选择。