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)

Feldman, T. et al. (2016) 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). Circulation: Heart Failure, 9(7), e003025. (doi:10.1161/CIRCHEARTFAILURE.116.003025) (PMID:27330010)

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Abstract

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.

Item Type:Articles
Additional Information:The study is funded entirely by Corvia Medical, Inc (Tewksbury, MA).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Cleland, Professor John
Authors: Feldman, T., Komtebedde, J., Burkhoff, D., Massaro, J., Maurer, M. S., Leon, M. B., Kaye, D., Silvestry, F. E., Cleland, J. G.F., Kitzman, D., Kubo, S. H., Van Veldhuisen, D. J., Kleber, F., Trochu, J.-N., Auricchio, A., Gustafsson, F., Hasenfuβ, G., Ponikowski, P., Filippatos, G., Mauri, L., and Shah, S. J.
Subjects:R Medicine > R Medicine (General)
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:Circulation: Heart Failure
Publisher:American Heart Association
ISSN:1941-3289
Published Online:21 June 2016
Copyright Holders:Copyright © 2016 American Heart Association Inc.
First Published:First published in Circulation: Heart Failure 9(7): e003025
Publisher Policy:Reproduced in accordance with the publisher copyright policy

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