用于治疗心力衰竭的经导管房间隔分流装置：降低心力衰竭患者升高的左心房压力的随机试验（REDUCE LAP-HF I）的原理与设计
Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure: Rationale and Design of the Randomized Trial to REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I).
作者信息
Feldman Ted, Komtebedde Jan, Burkhoff Daniel, Massaro Joseph, Maurer Mathew S, Leon Martin B, Kaye David, Silvestry Frank E, Cleland John G F, Kitzman Dalane, Kubo Spencer H, Van Veldhuisen Dirk J, Kleber Franz, Trochu Jean-Noël, Auricchio Angelo, Gustafsson Finn, Hasenfuβ Gerd, Ponikowski Piotr, Filippatos Gerasimos, Mauri Laura, Shah Sanjiv J
机构信息
From the NorthShore University Health System, Evanston Hospital, IL (T.F.); Corvia Medical Incorporated, Tewksbury, MA (J.K.); Columbia University Medical Center, New York Presbyterian Hospital, New York City, NY (D.B., M.S.M., M.B.L.); Harvard Clinical Research Institute, Boston University School of Public Health, MA (J.M.); Alfred Hospital and Baker IDI Heart and Diabetes Institute Melbourne, Australia (D.K.); Hospital of the University of Pennsylvania, Philadelphia (F.E.S.); National Heart and Lung Institute, Royal Brompton and Harefield Hospitals, Imperial College, London (J.G.F.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.K.); University of Minnesota, Minneapolis (S.H.K.); University Medical Center Groningen, University of Groningen, The Netherlands (D.J.V.V.); Cardio Centrum Berlin, Academic Teaching Institution, Charité University Medicine Berlin, Germany (F.K.); Université de Nantes, Institut du thorax, Centre Hospitalier Universitaire Nantes, France (J.-N.T.); Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland (A.A.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (F.G.); August Universität, Gottingen, Germany (G.H.); Department of Cardiac Diseases, Military Hospital, Medical University, Wroclaw, Poland (P.P.); National and Kapodistian University of Athens, School of Medicine, Attikon University Hospital, Greece (G.F.); Division of Cardiology, Harvard Clinical Research Institute, Brigham and Women's Hospital, Boston, MA (L.M.); and Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.S.).
出版信息
Circ Heart Fail. 2016 Jul;9(7). doi: 10.1161/CIRCHEARTFAILURE.116.003025.
UNLABELLED
Heart failure with preserved ejection fraction (HFpEF), a major public health problem with high morbidity and mortality rates, remains difficult to manage because of a lack of effective treatment options. Although HFpEF is a heterogeneous clinical syndrome, elevated left atrial pressure-either at rest or with exertion-is a common factor among all forms of HFpEF and one of the primary reasons for dyspnea and exercise intolerance in these patients. On the basis of clinical experience with congenital interatrial shunts in mitral stenosis, it has been hypothesized that the creation of a left-to-right interatrial shunt to decompress the left atrium (without compromising left ventricular filling or forward cardiac output) is a rational, nonpharmacological strategy for alleviating symptoms in patients with HFpEF. A novel transcatheter interatrial shunt device has been developed and evaluated in patients with HFpEF in single-arm, nonblinded clinical trials. These studies have demonstrated the safety and potential efficacy of the device. However, a randomized, placebo-controlled evaluation of the device is required to further evaluate its safety and efficacy in patients with HFpEF. In this article, we give the rationale for a therapeutic transcatheter interatrial shunt device in HFpEF, and we describe the design of REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I), the first randomized controlled trial of a device-based therapy to reduce left atrial pressure in HFpEF.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02600234.
未标注
射血分数保留的心力衰竭（HFpEF）是一个发病率和死亡率都很高的重大公共卫生问题，由于缺乏有效的治疗选择，其治疗仍然很困难。尽管HFpEF是一种异质性临床综合征，但无论静息时还是运动时左心房压力升高，都是所有形式HFpEF的共同因素，也是这些患者出现呼吸困难和运动不耐受的主要原因之一。基于二尖瓣狭窄先天性房间隔分流的临床经验，有人提出通过建立从左向右的房间隔分流来降低左心房压力（不影响左心室充盈或心输出量）是一种合理的、非药物性的缓解HFpEF患者症状的策略。一种新型经导管房间隔分流装置已被开发出来，并在单臂、非盲法临床试验中对HFpEF患者进行了评估。这些研究证明了该装置的安全性和潜在疗效。然而，需要对该装置进行随机、安慰剂对照评估，以进一步评估其在HFpEF患者中的安全性和疗效。在本文中，我们阐述了治疗性经导管房间隔分流装置用于HFpEF的理论依据，并描述了心力衰竭降低升高的左心房压力（REDUCE LAP-HF I）试验的设计，这是第一项基于装置治疗降低HFpEF患者左心房压力的随机对照试验。
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