预约演示

更新于：2025-05-07

Refractory heart failure

难治性心力衰竭

更新于：2025-05-07

基本信息

别名

Refractory heart failure、Refractory heart failure (diagnosis)、Refractory heart failure (disorder)

+ [1]

简介-

关联

项与难治性心力衰竭相关的临床试验

NCT06310031

/ RecruitingN/A

Investigation of a Novel, magNetically Levitated VAD for the Treatment of refractOry Left Ventricular heArT failurE

The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

开始日期2024-10-28

申办/合作机构

BrioHealth Solutions, Inc.

NCT06578520

/ Recruiting临床4期IIT

Effect of the Use of Dapagliflozin in Diuresis, Natriuresis and in Ultrafiltration and Peritoneal Elimination of Sodium, in Patients With Refractory Heart Failure

Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.

开始日期2024-07-30

申办/合作机构-

CTIS2023-505571-78-00

/ Recruiting临床4期IIT

EFFECT OF THE USE OF DAPAGLIFLOZIN IN DIURESIS, NATRIURIESIS AND IN ULTRAFILTRATION AND PERITONEAL ELIMINATION OF SODIUM, IN PATIENTS WITH REFRACTORY HEART FAILURE (DAPA-DP study)

开始日期2024-05-16

申办/合作机构-

100 项与难治性心力衰竭相关的临床结果

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100 项与难治性心力衰竭相关的转化医学

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0 项与难治性心力衰竭相关的专利（医药）

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1,987

项与难治性心力衰竭相关的文献（医药）

2025-12-01·European Journal of Trauma and Emergency Surgery

Evaluating factors associated with the use of extracorporeal membrane oxygenation in major trauma – an analysis of the TraumaRegister DGU®

Article

作者: Eimer, Christine ; Bauer, Andreas K ; Lepper, Philipp M ; Schober, Jonathan ; Ring, Matthias ; Ajouri, Jonas ; Muellenbach, Ralf ; Hossfeld, Bjoern ; Lefering, Rolf ; Achatz, Gerhard ; Kulla, Martin ; Feth, Maximilian

AbstractPurposeThere is increasing evidence that use of ECMO is beneficial in major trauma patients with refractory organ failure. Hence, increased numbers of ECMO support following major trauma are reported. We set out to determine the use of ECMO among major trauma patients submitted to the TraumaRegister DGUr® as well as patient features associated with ECMO support.MethodsThe TraumaRegister DGU® is a multinational database compiling trauma related health care data from point-of-injury, initial and critical care to outcome. Major trauma cases (AIS ≥ 3 irrespective of injury location) with subsequent critical care as well as respiratory and/or circulatory failure (SOFA score ≥ 3 per respective category) enrolled in the TraumaRegister DGU® between 2015 and 2022 were reviewed. A logistic regression model was carried out to evaluate patient features associated with ECMO support.Results410/ 22,548 individuals (1.8%) received ECMO support. Survival among ECMO patients was 46.1%. At discharge, good functional outcome as indicated by a Glasgow outcome scale > 3 was observed for 97 ECMO patients (23.6%). Age > 65 (OR 95%-CI 1.90, 1.52–2.60), male sex (OR 1.49, 95%-CI 1.41–1.95), coagulopathy at admission to the emergency department (OR 2.37, 95%-CI 1.88-3.00), chest trauma (OR 2.12, 95%-CI 1.61–2.81), sepsis (OR 2.94, 95%-CI 1.93–2.97), as well as massive transfusion (OR 2.23, 95%-CI1.56-3.19) were associated with the use of ECMO following trauma.ConclusionIn the TraumaRegister DGU®, ECMO for trauma related organ failure remains rare. Among ECMO patients, good functional outcome was observed infrequently. However, the design of the registry did not allow for capturing granular data on ECMO management and timing of organ failure. Hence, outcome data should be interpreted with caution. Nevertheless, evaluation of factors associated with ECMO support after trauma might contribute to early identification of ECMO candidates and improve patient distribution for trauma centers without ECMO capability.

2025-03-01·Journal of Cardiology Cases

A breast cancer patient with chemotherapy-induced chronic lymphocytic myocarditis successfully treated with steroid therapy

Article

作者: Matsumura, Yasushi ; Yamane, Haruya ; Nakamura, Masayuki ; Ikeoka, Kuniyasu ; Mishima, Tsuyoshi ; Kobata, Risako ; Inoue, Koichi ; Mori, Kiyoshi ; Abe, Haruhiko ; Ueda, Yasunori

A 63-year-old female patient with a history of postoperative recurrence of breast cancer after radiation therapy underwent chemotherapy with epirubicin (total 960 mg) and low-dose cyclophosphamide. She developed acute decompensated heart failure with reduced ejection fraction. Despite initial treatment with diuretics and inotropic drugs, her condition worsened, leading to low-output syndrome and frequent paroxysmal atrial fibrillation (AF). The patient underwent an endomyocardial biopsy and catheter ablation for AF. The endomyocardial biopsy revealed predominant lymphocyte invasion rather than cardiomyocyte injury, indicating drug-induced chronic lymphocytic myocarditis. The clinical course and biopsy findings indicated that other potential causes were unlikely, such as viral infection, collagen disease, and immune checkpoint inhibitor use. Following steroid pulse therapy, maintenance therapy with a starting dose of 80 mg of methylprednisolone (mPSL) led to a significant improvement in hemodynamics, resulting in her discharge on the 82nd day with an improved ejection fraction from 20 % to 42 %. A second endomyocardial biopsy under 20 mg of mPSL showed a marked improvement in lymphocytic infiltration. This case serves to illustrate the significance of endomyocardial biopsy in the context of refractory heart failure with an onco-cardiology case, whereby an appropriate diagnosis can be made and successful steroid therapy can be initiated.Learning objectiveAlthough heart failure after chemotherapy is frequently reported, reports of chronic lymphocytic myocarditis after chemotherapy are relatively uncommon. Endomyocardial biopsy has enabled the differential diagnosis of cardiac toxicity and has led to the diagnosis of lymphocytic myocarditis. Currently, the optimal treatment for chronic lymphocytic myocarditis remains unestablished. However, in this case, it was found that steroid therapy was effective.

2025-03-01·The Journal of Heart and Lung Transplantation

Design and rationale for the clinical investigation of a novel, magnetically levitated left ventricular assist device for the treatment of refractory heart failure

Article

作者: Naka, Yoshifumi ; Jorde, Ulrich P ; Cowger, Jennifer A ; Pagani, Francis D ; Milano, Carmelo ; Long, James W ; Druker, Vitaly ; Bhat, Geetha ; Salerno, Christopher

BACKGROUNDContemporary durable left ventricular assist devices (LVAD) have established current benchmarks for patient outcomes, but introduction of more novel technology is lacking. The BrioVAD System (BrioHealth Solutions, Burlington, MA) is an innovative, fully magnetically levitated pump intended to provide short-term (ST) and long-term (LT) mechanical circulatory support.METHODSThe Investigation of a Novel, MagNetically Levitated VAD for the Treatment of RefractOry Left Ventricular HeArT FailurE Clinical Trial (INNOVATE) is designed to evaluate safety and efficacy of the BrioVAD by demonstrating non-inferiority to the HeartMate 3 (HM3; Abbott Labs, Chicago, IL). INNOVATE is a multi-center, prospective, non-blinded, randomized (2 BrioVAD: 1 HM3), controlled, non-inferiority study designed as a staged pivotal study with a pre-defined safety phase. Exclusion criteria are designed to enroll a patient population that aligns with contemporary clinical practice. Primary endpoints include a composite of survival to transplant, cardiac recovery, or 6 months (ST) or 24 months (LT) of LVAD support free from debilitating stroke (modified Rankin Scale > 3), or reoperation to replace the pump. A powered secondary outcome evaluates days spent in hospital, skilled nursing facility, or inpatient rehabilitation.RESULTSINNOVATE study screening and enrollment began in 2024. Completed enrollment of the safety cohort (n = 45) is projected in early 2025. Completion of the ST cohort (n = 237) and LT cohort (n = 402) is projected for 2026 and 2027, respectively.CONCLUSIONSINNOVATE represents a contemporary clinical trial design evaluating unique design features of the BrioVAD System with the expectation to improve patient outcomes.

项与难治性心力衰竭相关的新闻（医药）

2024-11-27

·BioBAY

开创历史！同心医疗美国首例BrioVAD®临床植入成功，树立我国人工心脏领域国际里程碑

近日，BioBAY孵化企业同心医疗宣布其自主研发的全磁悬浮左心室辅助装置BrioVAD®在美国埃默里大学医院完成了INNOVATE临床试验首例患者入组。这一里程碑事件标志着同心医疗在全球心力衰竭治疗领域取得了重大突破，同时也展示了我国在人工心脏领域的国际竞争力。同心医疗创始人陈琛博士表示：“我们怀着异常兴奋的心情启动了INNOVATE临床试验，我们经历了持续的创新、打磨和品质优化的长途跋涉后，赋予了BrioVAD®生命。尽管心室辅助装置领域已取得进步，但仍然迫切需要提高设备性能和患者预后，同心医疗致力于弥补这一不足。参与中心通过本次试验推动晚期心衰治疗的极大热情，令我们感觉到非常欣慰。” 同心医疗于2008年在苏州工业园区成立，经过十多年源头创新，成功开发了新一代超小型全磁悬浮人工心脏慈孚®VAD（型号：CH-VAD），成为我国首个获得国家药品监督管理局批准上市的拥有完备自主知识产权的全磁悬浮植入式左心室辅助装置。目前，中国已有超过350名患者接受了CH-VAD的治疗，并展现了卓越的临床效果。BrioVAD®与CH-VAD具有相同的植入式血泵，且通过多项技术创新，实现了体外部件的便携化和系统整体性能的提升。 BrioVAD®系统是一种能提供全流量支持的耐久型VAD，由可植入的血泵和外部组件组成，旨在为心衰患者提供长期支持。与目前唯一获得美国FDA批准的耐久型VAD相比，BrioVAD®血泵采用了创新的分立式磁悬浮设计，实现了更小泵体与大叶轮的完美结合，有助于减少手术创伤。此外，BrioVAD®还采用了创新的经皮电缆设计，更细、更柔软的经皮电缆有助于降低相关的感染风险。 BrioVAD®血泵独特的磁悬浮结构和大直径叶轮也为泵内流道的优化提供了基础。先进的流道设计有助于有提升设备的血液相容性和血流动力学性能，从而降低严重并发症的风险。 BrioVAD®系统的外部组件采用了多项独特设计，患者日常仅需佩戴两个组件，有助于提升用户体验和患者的生活质量。 INNOVATE试验是一项前瞻性、非盲、随机、对照、多中心、非劣效性研究，将直接与此前FDA批准的唯一一款全磁悬浮人工心脏进行随机对照，旨在全面评估BrioVAD®在治疗难治性心力衰竭方面的有效性与安全性。该试验的启动对于推动全球心室辅助装置领域的创新和发展具有重要意义。密西根大学医学院心脏外科Otto Gago讲席教授、本研究的牵头研究者Francis D. Pagani博士表示：“晚期心力衰竭患者的治疗选择有限，目前美国仅有一种LVAD可供使用。尽管治疗手段有所进步，LVAD患者仍会出现各种并发症。INNOVATE试验将验证BrioVAD®系统是否有助于进一步减少并发症，并改善晚期心力衰竭患者的生活质量。” 埃默里大学医学院Andrew J. McKelvey讲席教授、埃默里心肺移植与机械循环支持项目主任Mani Daneshman博士表示：“INNOVATE试验的启动是拓展晚期心衰患者治疗选择的重要里程碑，我们很期待看到BrioVAD®系统如何造福这些患者。” 随着BrioVAD®在美国临床试验的顺利启动，同心医疗不仅开创了我国人工心脏行业进入美国临床试验的先河，也树立了国际心力衰竭治疗领域的里程碑，同心医疗有望打破全球人工心脏行业格局。 ▌文章来源：同心医疗责编：赵家帅审核：任旭推荐阅读同心医疗、宜明生物入选2024年市工程技术研究中心拟认定名单亚盛医药、纽福斯、英矽智能、同心医疗上榜！《麻省理工科技评论》公布2021年度“50家聪明公司” 同心医疗：首个国产全磁悬浮VAD获批上市入选《中国2021年度重要医学进展》

申请上市临床研究

2024-05-01

·PRNewswire

BrioHealth Solutions Secures Nod from FDA to Begin the INNOVATE Trial Featuring the BrioVAD™ System for Advanced Heart Failure

BURLINGTON, Mass., May 1, 2024 /PRNewswire/ -- BrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, today announced it has received FDA Investigational Device Exemption (IDE) approval with conditions to commence enrollment in its landmark INNOVATE trial. The study will assess the effectiveness and safety of its novel BrioVAD™ System, a magnetically levitated ventricular assist device, in treating refractory left ventricular heart failure. With the notice, BrioHealth Solutions has initiated clinical site start-up activities in the US. The BrioVAD Left Ventricular Assist System is designed to aid patients suffering from advanced heart failure, offering both temporary and long-term support solutions. The BrioVAD System consists of a novel hemocompatible blood pump with a fully magnetically levitated rotor and two small, lightweight, patient-worn components. This advanced technology is designed to help patients overcome the limitations of heart failure and enhance quality of life. The BrioVAD system will be evaluated in the INNOVATE trial randomized relative to technology previously approved by the FDA. "Achieving this stage of FDA approval for the INNOVATE trial marks an important step in providing more options to clinicians and patients seeking advanced heart failure therapies," said Francis D. Pagani, M.D., Ph.D., the Otto Gago MD Endowed Professor in Cardiac Surgery at the University of Michigan and the study's National Principal Investigator. "The clinical evaluation of the BrioVAD System is a significant leap forward for the entire field of heart failure. Countless patients go untreated each year and continue to suffer with this seriously debilitating condition," Dr. Pagani emphasized. "We are excited to have achieved this crucial milestone. Our goal is to deliver patient-centered solutions for advanced heart failure patients and their families," remarked Chen Chen, Ph.D. CEO of BrioHealth Solutions. "The innovative BrioVAD System, with its compact pump designed for hemocompatibility along with small, lightweight peripherals, has been engineered to restore patients back to active lifestyles." About BrioHealth Solutions: BrioHealth Solutions is developing the BrioVAD™ System, a left ventricular assist system representing a significant advanced heart failure innovation. The company's founding mission is a commitment to restoring, extending and enhancing the lives of patients globally by collaborating with healthcare providers to push the boundaries of what's possible and deliver the best medical technologies and solutions. The BrioVAD System is an investigational device limited by federal law for investigational use only. For more information on BrioHealth Solutions, please visit the company website at and follow us on LinkedIn @BrioHealthSolutions and Twitter/X @BrioVAD. SOURCE BrioHealth Solutions, Inc.

临床研究

2024-01-11

·PRNewswire

BrioHealth Solutions Launches New Corporate Identity and Prepares for Groundbreaking INNOVATE Trial for Advanced Heart Failure Treatment

BURLINGTON, Mass., Jan. 11, 2024 /PRNewswire/ -- BrioHealth Solutions, Inc. announced today an official name change from CH Biomedical (USA) to BrioHealth Solutions, unveiling a new corporate identity that aligns with its mission to expand healthcare solutions for restoring, enhancing, and extending lives. The new corporate brand is consistent with the company's strategic vision to collaborate with healthcare providers and make a profound impact on advanced heart failure, a condition that poses significant challenges to patients and their families. Chen Chen, PhD, CEO of BrioHealth Solutions, expressed excitement about the company's evolution, stating, "As we enter 2024, aligning our company identity with our key goals is the first step in a milestone year. We are excited to be preparing for the initiation of our INNOVATE Trial with the BrioVAD™ System." The Investigation of a Novel, Magnetically Levitated VAD for the Treatment of Refractory left Ventricular Heart Failure (INNOVATE) Trial represents a crucial next step in demonstrating the clinical performance of the BrioVAD™ System, a left ventricular assist system designed to address refractory advanced heart failure in the United States. The INNOVATE trial will, upon FDA approval of the IDE application, enroll and evaluate the BrioVAD System in patients for both short-term (6-month endpoint) and long-term (24-month endpoint) indications. Headquartered in Burlington, Massachusetts, BrioHealth Solutions is expanding its US organization to meet the challenges of developing and introducing innovative technologies for advanced heart failure patients. Justin Callaway, COO, and Senior VP of R&D noted the company's dedication to addressing unmet needs in this underserved patient population, stating, "We see the statistics. There are a large number of unidentified and untreated advanced heart failure patients, and the limited number of donor organs cannot address all of them. We believe BrioHealth Solutions and the BrioVAD™ System will play an essential role in helping these patients and their families." About BrioHealth Solutions: BrioHealth Solutions is developing the BrioVAD™ System, a Left Ventricular Assist System representing a significant advance in the heart failure treatment space. The company is committed to restoring, extending, and enhancing the lives of patients globally by collaborating with healthcare providers to push the boundaries of what's possible and deliver the best medical technologies and solutions. For more information on BrioHealth Solutions, please visit the company website at and follow us on LinkedIn @BrioHealthSolutions and Twitter/X @BrioVAD SOURCE BrioHealth Solutions, Inc.

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