The first-of-its-kind TEAM-HF study seeks to improve clinical outcomes in patients with worsening heart failureTrial establishes new, objective criteria to identify patients most at risk for developing end-stage heart failure and potentially offer life-saving therapeutic options sooner in their disease progressionABBOTT PARK, Ill., Oct.

首次同类TEAM-HF研究旨在改善心力衰竭恶化患者的临床结果。该试验建立了新的客观标准，以确定最有可能发展为终末期心力衰竭的患者，并可能在疾病进展中尽早提供挽救生命的治疗选择。伊利诺伊州阿伯特公园，10月。

24, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced a new, first-of-its-kind clinical trial designed to improve outcomes in patients with worsening heart failure who could benefit from advanced therapy options. The TEAM-HF trial, which is planned to enroll up to 850 patients across 75 sites worldwide, will measure pulmonary artery pressures (PAP) using Abbott's CardioMEMS™ HF System to objectively identify advanced heart failure patients at high risk of mortality who could benefit from a life-saving HeartMate 3™ left ventricular assist device (LVAD, or heart pump) earlier in their disease progression..

2024年4月24日/新闻通讯社/--雅培（纽约证券交易所：ABT）今天宣布了一项新的同类临床试验，旨在改善心力衰竭恶化患者的预后，这些患者可能会从先进的治疗方案中受益。TEAM-HF试验计划在全球75个地点招募多达850名患者，该试验将使用雅培的CardioMEMS™HF系统测量肺动脉压（PAP），以客观地识别死亡风险高的晚期心力衰竭患者，这些患者可能在疾病进展早期受益于挽救生命的HeartMate 3™左心室辅助装置（LVAD或心脏泵）。。

Heart failure is a progressive condition that occurs when the heart can't circulate blood efficiently, resulting in symptoms such as fatigue, breathlessness, and swollen ankles. Approximately 6.7 million people in the United States have heart failure, and that number is expected to rise to 8.5 million by 2030.1 While there are currently evidence-based guidelines for treating patients with advanced therapies (either LVADs or heart transplantation) when they are in end-stage heart failure, there are fewer objective criteria for identifying patients who are earlier in their disease progression.

心力衰竭是一种进行性疾病，当心脏不能有效地循环血液时，就会出现疲劳、呼吸困难和脚踝肿胀等症状。美国约有670万人患有心力衰竭，预计到2030年这一数字将增至850万。1虽然目前有循证指南用于治疗晚期治疗（LVAD或心脏移植）的患者，但终末期心力衰竭患者的客观标准较少。

This can result in patients being offered advanced therapies such as an LVAD when their heart failure has become too advanced, leading to poorer outcomes, and even death..

这可能导致患者在心力衰竭变得过于严重时接受 LVAD 等高级疗法，从而导致结果恶化，甚至死亡。

'The goal of the TEAM-HF trial is simple in concept but critical to the future care of patients. We want to break down patient care silos, offering a unified effort to not only improve the diagnosis of advanced heart failure, but also enable rapid access to life saving heart pumps. This study aims to take the guess work out of deciding when a patient has reached the ideal time for LVAD implementation,' said Jennifer Cowger, M.D., medical director of mechanical circulatory support and section head of the advanced heart failure program at Detroit-based Henry Ford Health, and one of the national co-principal investigators for the TEAM-HF trial.

“TEAM-HF试验的目标在概念上很简单，但对患者的未来护理至关重要。我们希望打破患者护理孤岛，提供统一的努力，不仅可以改善晚期心力衰竭的诊断，还可以快速获得挽救生命的心脏泵。位于底特律的亨利·福特健康公司（HenryFordHealth）机械循环支持医学主任、高级心力衰竭项目科长、TEAM-HF试验的国家联合首席研究员之一、医学博士詹妮弗·考格（JenniferCowger）说，这项研究旨在排除猜测，以确定患者何时达到实施LVAD的理想时间。

'Too many patients are not receiving timely access to this life-saving therapy and are needlessly dying of heart failure. The importance of patient access to multidisciplinary heart failure care is embodied in the trial acronym - TEAM-HF - and we feel this study will be instrumental in helping providers identify patients who may benefit from a heart pump earlier in their care journey.'.

患者获得多学科心力衰竭护理的重要性体现在试验缩写词TEAM-HF中，我们认为这项研究将有助于帮助提供者识别可能在护理过程早期受益于心脏泵的患者。”

TEAM-HF: Deploying a New Approach to Therapy DecisionsPatients with end-stage heart failure who rely on IV-administered heart failure medications designed to strengthen the heart's blood pumping ability have poor outcomes with a median survival of nine months.2 Guideline recommendations for treating patients who depend on these medications include advanced therapies such as LVADs.

TEAM-HF：部署一种新的治疗决策方法终末期心力衰竭患者依赖静脉注射心力衰竭药物来增强心脏的泵血能力，结果不佳，中位生存期为9个月。2治疗依赖这些药物的患者的指南建议包括LVAD等先进疗法。

However, patients who are not yet dependent on medication also have a poor clinical prognosis but are often not referred for these advanced options until their symptoms worsen. This delay is partly due to the lack of objective measures to identify patients who would most benefit from an LVAD..

然而，尚未依赖药物治疗的患者的临床预后也很差，但通常在症状恶化之前不会被转介接受这些先进的选择。这种延迟部分是由于缺乏客观的措施来确定最能从LVAD中受益的患者。

The TEAM-HF trial will deploy a novel approach to assess the impact of earlier interventions in patients with worsening heart failure. Investigators will first examine PAP data securely collected from participants using Abbott's CardioMEMS™ HF System. The CardioMEMS sensor, placed in the pulmonary artery during a minimally invasive outpatient procedure, monitors pulmonary artery pressure changes over time.

TEAM-HF试验将部署一种新方法来评估早期干预对心力衰竭恶化患者的影响。研究人员将首先检查使用雅培CardioMEMS™HF系统从参与者那里安全收集的PAP数据。CardioMEMS传感器在微创门诊手术期间放置在肺动脉中，监测肺动脉压力随时间的变化。

If pressures do not go down with guideline directed medical therapy, the TEAM-HF trial will seek to prove that such patients will benefit from advanced therapies. These patients will be randomized to receive either the HeartMate 3 LVAD implant or continued treatment with their existing heart failure medications.

如果指南指导的药物治疗没有降低压力，TEAM-HF试验将试图证明这些患者将从先进的治疗中受益。这些患者将被随机分配接受HeartMate 3 LVAD植入物或继续使用现有的心力衰竭药物治疗。

Patients whose existing medications reduce their PAP levels will enter a single arm registry where they will continue to be managed based on data from their CardioMEMS sensor..

现有药物降低PAP水平的患者将进入单臂登记处，在那里他们将继续根据他们的CardioMEMS传感器的数据进行管理。

'As the only healthcare company in the world that has developed medical devices designed to treat people at each stage of heart failure, our hope is that the TEAM-HF study will revolutionize care management for these patients and their families. Getting people on a heart pump more quickly could mean more time spent out of the hospital and with loved ones,' said Keith Boettiger, vice president, Abbott's heart failure business.

“作为世界上唯一一家开发出用于治疗心力衰竭各个阶段患者的医疗设备的医疗保健公司，我们希望TEAM-HF研究将彻底改变这些患者及其家属的护理管理。雅培心力衰竭业务副总裁基思·博蒂格（KeithBoettiger）说，让人们更快地使用心脏泵可能意味着有更多的时间离开医院和与亲人在一起。

'By having more objective methods to accurately gauge heart failure progression and refer people to receive this life-saving therapy faster, healthcare experts will be able to provide patients with improved survival rates and quality of life based on the anticipated results of the TEAM-HF study.'.

“通过采用更客观的方法来准确测量心力衰竭的进展，并更快地推荐人们接受这种挽救生命的治疗，医疗专家将能够根据TEAM-HF研究的预期结果为患者提供更高的生存率和生活质量。”

Enrollment in TEAM-HF will commence shortly at sites across the U.S. The trial's powered primary and secondary endpoints will be evaluated at two years, with long-term follow up through five years.

TEAM-HF的注册不久将在美国各地开始。该试验的主要和次要终点将在两年内进行评估，并进行为期五年的长期随访。

Decisions regarding the medical management of HeartMate 3 patients should be done by clinicians after fully considering potential risks and benefits for each individual.

临床医生应在充分考虑每个人的潜在风险和益处后，做出有关HeartMate 3患者医疗管理的决定。

About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries..

关于Abbott Abbott是一家全球医疗保健领导者，致力于帮助人们在生命的各个阶段都生活得更加充实。我们的114000名同事为160多个国家的人民服务。