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启动和滴定指导性药物治疗心力衰竭心力衰竭，并用Impella 5.5进行心脏恢复（整合） (INTeGRATE)

2026年11月10日 更新者：Abiomed Inc.

启动和滴定指导性药物治疗在心力衰竭心脏病休克中使用Impella 5.5进行心脏恢复：整合

The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a prospective, single arm, multi-center, post-market, on-label study. For patients presenting with cardiogenic shock in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis (also known as decompensated heart failure complicated with cardiogenic shock, commonly referred to as heart failure-related cardiogenic shock, HF-CS, including both acute-on-chronic and de novo presentations) as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP), an intentional device-supported strategy with Impella 5.5™ for optimization of guideline-directed medical therapy (GDMT) combined with best practices improves outcomes over standard of care.

研究类型

介入性

注册 (估计的)

250

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Roberta Chapman, MD, FACC, FACP, FHFSA
  • 电话号码：+1 978-882-8421
  • 邮箱：rchapm11@its.jnj.com

研究联系人备份

学习地点

  • 美国
    • California
      • Sacramento、California、美国、95816
        • 尚未招聘
        • Sutter Medical Center Sacramento
        • 首席研究员：
          • Michael Gibson, MD
        • 接触：
      • San Francisco、California、美国、94110
        • 尚未招聘
        • California Pacific Medical Center
        • 接触：
        • 首席研究员：
          • Jared Herr, MD
        • 首席研究员：
          • Michael Pham, M.D., FACC, MPH
    • Florida
      • Naples、Florida、美国、34102
        • 尚未招聘
        • NCH Rooney Heart Institute
        • 接触：
        • 首席研究员：
          • Viviana Navas, MD
      • Tampa、Florida、美国、33606
        • 招聘中
        • Tampa General Hospital
        • 接触：
        • 首席研究员：
          • Debbie Rinde-Hoffman, MD, FACC, FACP, FHFSA
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • 尚未招聘
        • Ascension St. Vincent
        • 接触：
        • 首席研究员：
          • Sunit-Preet Chaudhry, MD, FACC
    • Minnesota
      • Minneapolis、Minnesota、美国、555407
        • 招聘中
        • Abbott Northwestern
        • 接触：
        • 首席研究员：
          • Kasia Hryniewicz, MD
    • Missouri
      • St Louis、Missouri、美国、63110
        • 尚未招聘
        • Barnes Jewish
        • 接触：
        • 首席研究员：
          • Justin Vader, MD, MPHS
    • New Jersey
      • Hackensack、New Jersey、美国、07601
        • 尚未招聘
        • Hackensack University Medical Center
        • 首席研究员：
          • Kanika Mody, MD
        • 接触：
      • New Brunswick、New Jersey、美国、08901
        • 招聘中
        • Rutgers-Robert Wood Johnson Medical School
        • 接触：
        • 首席研究员：
          • Maya Guglin, MD, PhD
    • New York
      • New York、New York、美国、10032
        • 尚未招聘
        • New York Presbyterian - Columbia
        • 首席研究员：
          • Adil Yunis, MD
        • 接触：
      • Valhalla、New York、美国、10595
        • 尚未招聘
        • Westchester Medical Center
        • 首席研究员：
          • Alan Gass, MD
        • 接触：
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • 尚未招聘
        • Atrium Health- Sanger Heart and Vascular Institute
        • 接触：
        • 首席研究员：
          • Priyesh Patel, M.D.
      • Durham、North Carolina、美国、27710
        • 尚未招聘
        • Duke University
        • 接触：
        • 首席研究员：
          • Adam DeVore, MD, MHS, FHFSA, FAHA, FACC
      • Winston-Salem、North Carolina、美国、27157
        • 尚未招聘
        • Wake Forest Baptist Medical Center
        • 接触：
        • 首席研究员：
          • Olivia Gilbert, MD
    • Oklahoma
      • Tulsa、Oklahoma、美国、74136
        • 尚未招聘
        • Saint Francis Hospital - Tulsa
        • 首席研究员：
          • Jaime Hernandez-Montfort, MD
        • 接触：
    • Oregon
      • Portland、Oregon、美国、97225
        • 尚未招聘
        • Providence St. Vincent Medical Center
        • 接触：
        • 首席研究员：
          • Vidang Nguyen, MD
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • 尚未招聘
        • University of Pennsylvania Health System
        • 接触：
        • 首席研究员：
          • Joyce Wald, DO, FACC
      • Pittsburgh、Pennsylvania、美国、15212
        • 尚未招聘
        • Allegheny General Hospital
        • 首席研究员：
          • Matthew Lander, MD
        • 接触：
      • Pittsburgh、Pennsylvania、美国、15213
        • 尚未招聘
        • UPMC Presbyterian
        • 接触：
        • 首席研究员：
          • Sideris Facaros, MD
    • Tennessee
      • Nashville、Tennessee、美国、32703
        • 尚未招聘
        • Centennial Medical Center
        • 接触：
        • 首席研究员：
          • Thomas McRae, MD, FACC
        • 首席研究员：
          • Zachary J II'Giovine, MD, FACC
    • Texas
      • Dallas、Texas、美国、75243
        • 招聘中
        • Medical City Heart Hospital Dallas
        • 接触：
        • 首席研究员：
          • Song Li, MD
    • Utah
      • Salt Lake City、Utah、美国、84132
        • 尚未招聘
        • University of Utah
        • 首席研究员：
          • Stavros Drakos, MD
        • 接触：
        • 首席研究员：
          • Thomas Hanff, MD
    • Virginia
      • Falls Church、Virginia、美国、22042
        • 尚未招聘
        • Inova Fairfax Hospital
        • 首席研究员：
          • Shashank Sinha, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age ≥ 18 and < 80 years

  2. Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form

  3. LVEF ≤ 40%

  4. Subject is presenting with decompensated heart failure and meets at least two (2) of the following cardiogenic shock criteria:

    1. Hypotension (sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for inotropic/vasoactive agents to maintain such blood pressure)
    2. Hypoperfusion (physical sign(s) of organ hypoperfusion or serum lactate >2 mmol/L)
    3. Cardiac index (CI) < 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
    4. Required support with an intra-aortic balloon pump (IABP) or Impella CP™

  5. Subject has inadequate heart failure GDMT based on the most recent outpatient prescription prior to index admission, defined as:

    1. On 2 or less of the 4-Pillar HF Drug Classes (BB, MRA, SGLT2i, and RASi)
    2. If on BB and RASi, at least one of the two medications is < 50% of the maximal target dose

Exclusion Criteria:

  1. Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to:

    1. Drug allergies or hypersensitivities* to HF GDMT medications, unless alternative can be identified

      *Drug allergy/hypersensitivity is an immune-mediated reaction to a medication. Adverse reactions must be a result of immune or inflammatory cell stimulations by the mеԁiсаtion.

    2. Known bilateral renal artery stenosis

    3. Type 1 diabetes

    4. 2o or 3o AV block, unless pacemaker is in place

    5. Angioedema, hereditary or idiopathic

    6. Pregnancy, known or confirmed by a pregnancy test if of childbearing potential

  2. ST-segment elevation or acute coronary syndrome (ACS) prior to enrollment

  3. Septic shock, shock from non-cardiac origins, or mixed shock

  4. SCAI Stage E cardiogenic shock per study definition (Appendix C) prior to enrollment

  5. In cardiac arrest prior to enrollment

  6. Prolonged use (or use with complication) of Intra-aortic balloon pump (IABP) or Impella CP™ prior to enrollment, meeting at least one of the following:

    1. IABP use >24 hours if placed at the enrolling site or >48 hours if transferred on IABP
    2. Impella CP™ use >24 hours if placed at the enrolling site or >48 hours if transferred on Impella CP™
    3. Experienced complication(s) from IABP including clinically significant vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion
    4. Experienced complication(s) from Impella CP™ including clinically significant hemolysis, vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion

  7. On mechanical circulatory support other than IABP or Impella CP™ (i.e. ECMO, etc) or on mechanical ventilation for non-procedural reasons prior to enrollment

  8. Revascularization or cardiac surgery within 30-days prior to enrollment

  9. Infiltrative/restrictive cardiomyopathy (sarcoidosis and amyloidosis), hypertrophic cardiomyopathy, constrictive pericarditis, pericardiac tamponade, or myocarditis requiring high-dose immunosuppression

  10. Complex adult congenital heart disease

  11. Primary severe valvular disease

  12. Predominant RV dysfunction per Investigator's discretion

  13. History of heart transplant or listed for heart transplant or planned for heart transplantation prior to enrollment

  14. Planned to be implanted with a permanent VAD within 180-days of the index hospitalization date

  15. Continuous outpatient inotropic support prior to the index hospitalization date

  16. Planned to pursue palliative care or hospice, or life expectancy of less than 1 year due to non-cardiac illness at the time of index hospitalization date

  17. Currently on dialysis, or has pre-existing end-stage chronic kidney disease (stage 4 and above), or has nephropathy of hereditary, infectious, or autoimmune origin

  18. Pre-existing functional liver disease including liver cirrhosis, alcoholic hepatitis, metabolic dysfunction associated steatohepatitis (MASH), or genetic liver disease

  19. Pre-existing pulmonary disease with oxygen dependency

  20. History of stroke or intracranial hemorrhage ≤ 90 days prior to the index hospitalization date, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis, or any permanent neurological deficit with modified Rankin Scale (mRS) >2

  21. Any contraindication that precludes placing an Impella 5.5™, including but not limited to:

    1. Aortic valve stenosis/calcification with orifice area ≤ 0.6cm2 or aortic insufficiency of any grade greater than mild on pre-procedure echocardiography
    2. Presence of mechanical aortic valve or heart constrictive device
    3. Mural thrombus in the left ventricle
    4. Severe arterial disease precluding placement of Impella
    5. Presence of atrial or ventricular septal defect
    6. Left ventricular rupture
    7. Cardiac tamponade
    8. Combined cardiorespiratory failure

  22. Infection of the planned procedural access site or systemic active infection including sepsis and bacteremia

  23. Intolerance to anticoagulant or antiplatelet therapies, or will refuse blood transfusions

  24. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures

  25. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device

  26. Subject belongs to a vulnerable population, such as prisoners, pregnant women, handicapped, mentally disabled persons, or economically or educationally disadvantaged persons per 21CFR56.111(a)(3) and 111(b)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：Single arm study

This is a single arm study.
设备：Impella 5.5 SmartAssist

The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
全因死亡、心力衰竭住院和心脏置换（心脏移植或永久性LVAD植入）的复合终点
大体时间：入组后180天时间窗
入组后180天时间窗

次要结果测量

结果测量
措施说明
大体时间
全因死亡和心脏替代的复合终点
大体时间：90-days, 180-days, 1-year post-enrollment
90-days, 180-days, 1-year post-enrollment
全因死亡、心力衰竭住院和心脏替代疗法的复合终点
大体时间：入组后90天、1年
入组后90天、1年
全因死亡率
大体时间：出院（24小时内）、90天、180天、入组后1年
出院（24小时内）、90天、180天、入组后1年
心血管疾病死亡率
大体时间：出院（24小时内）、90天、180天、入组后1年
出院（24小时内）、90天、180天、入组后1年
全因死亡和心力衰竭恶化的复合终点
大体时间：入组后90天、180天、1年
入组后90天、180天、1年
非HF心血管住院
大体时间：入组后90天、180天、1年
入组后90天、180天、1年
所有（因）心血管住院病例
大体时间：入组后90天、180天、1年
入组后90天、180天、1年
全因死亡和所有心血管原因住院的复合终点
大体时间：入组后90天、180天、1年
入组后90天、180天、1年
LVEF 自基线起的变化
大体时间：出院后180天
出院后180天
LVEDD 较基线的变化
大体时间：出院后180天
出院后180天
NYHA心衰分级较基线的变化
大体时间：出院后180天
出院后180天
Worsening heart failure
大体时间：90-days, 180-days, 1-year post-enrollment

HF hospitalization or urgent HF visit
90-days, 180-days, 1-year post-enrollment
Rate of major device-related adverse events
大体时间：Hospital Discharge (within 24 hours), 30-days post-enrollment

The composite rate of any of the following device-related serious adverse events:

  1. Major vascular access site complication
  2. Major hemolysis
  3. Bleeding, defined as MCS-ARC Type 3 or higher
  4. Structural complication requiring repair
  5. Stroke
Hospital Discharge (within 24 hours), 30-days post-enrollment
Subjects achieving indicated GDMT treatment
大体时间：Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment

Achieving any dose of all four classes
Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
% of Subjects achieving optimized GDMT treatment
大体时间：90-days and 180-days post-enrollment

Achieving at least 50% of the target dose of all four classes
90-days and 180-days post-enrollment
Modified Heart Failure Collaboratory (mHFC) score
大体时间：Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment

Defined by HFC in 2022. Improvement from baseline
Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
Rate of GDMT-Related Serious Adverse Events
大体时间：Hospital Discharge (within 24 hours), 90-days, and 180-days post-enrollment

The composite rate of any of the following GDMT-related serious adverse events:

  1. Recurrence or worsening shock; symptomatic hypotension requiring admission
  2. Bradycardia requiring treatment
  3. Hyperkalemia requiring intervention
  4. Ketoacidosis requiring treatment
  5. Need for new renal replacement therapy (RRT)
Hospital Discharge (within 24 hours), 90-days, and 180-days post-enrollment
Quality of life assessed by EQ-5D
大体时间：180-days and 1-year post-discharge

improvement from baseline
180-days and 1-year post-discharge
6-Minute Walk Test Distance
大体时间：180-days and 1-year post-discharge

improvement from baseline
180-days and 1-year post-discharge
Change in HF biomarker
大体时间：Hospital Discharge (within 24 hours), 30-days, and 90-days post-discharge

NT-proBNP from baseline
Hospital Discharge (within 24 hours), 30-days, and 90-days post-discharge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Abiomed Inc.

合作者

Johnson & Johnson

调查人员

  • 首席研究员：Adam DeVore, MD, MHS、Duke University
  • 首席研究员：Gavin Hickey, MD、University of Pittsburgh
  • 首席研究员：Manreet Kanwar, MD、University of Chicago

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月2日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2025年4月21日

首先提交符合 QC 标准的

2025年5月2日

首次发布 (实际的)

2025年5月11日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • INTeGRATE

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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