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Design of the SILICOFCM study: Effect of sacubitril/valsartan vs lifestyle intervention on functional capacity in patients with hypertrophic cardiomyopathy.

Authors
  • Tafelmeier, Maria1
  • Baessler, Andrea1
  • Wagner, Stefan1
  • Unsoeld, Bernhard1
  • Preveden, Andrej2
  • Barlocco, Fausto3
  • Tomberli, Alessia3
  • Popovic, Dejana4
  • Brennan, Paul5
  • MacGowan, Guy A5
  • Ristic, Arsen4
  • Velicki, Lazar2
  • Olivotto, Iacopo3
  • Jakovljevic, Djordje G5
  • Maier, Lars S1
  • 1 Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany. , (Germany)
  • 2 Medical Faculty, University of Novi Sad, Novi Sad, Serbia and Institute of cardiovascular diseases of Vojvodina, Sremska Kamenica, Serbia. , (Serbia)
  • 3 Careggi University Hospital, University of Florence, Florence, Italy. , (Italy)
  • 4 Cardiology Department, Clinical Centre of Serbia, Faculties of Medicine and Pharmacy, University of Belgrade, Belgrade, Serbia. , (Serbia)
  • 5 Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.
Type
Published Article
Journal
Clinical cardiology
Publication Date
May 01, 2020
Volume
43
Issue
5
Pages
430–440
Identifiers
DOI: 10.1002/clc.23346
PMID: 32125709
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiovascular disease with a broad spectrum of disease severity. HCM ranges from a benign course to a progressive disorder characterized by angina, heart failure, malignant arrhythmia, syncope, or sudden cardiac death. So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms. While the angiotensin receptor neprilysin inhibitor sacubitril/valsartan has shown to reduce mortality and hospitalization in heart failure with reduced ejection fraction, data on its effect on HCM are sparse. A 4-month pharmacological (sacubitril/valsartan) or lifestyle intervention will significantly improve exercise tolerance (ie, peak oxygen consumption) in patients with nonobstructive HCM compared to the optimal standard therapy (control group). SILICOFCM is a prospective, multicenter, open-label, randomized, controlled, three-arm clinical trial (NCT03832660) that will recruit 240 adult patients with a confirmed diagnosis of nonobstructive HCM. Eligible patients are randomized to sacubitril/valsartan, lifestyle intervention (physical activity and dietary supplementation with inorganic nitrate), or optimal standard therapy alone (control group). The primary endpoint is the change in functional capacity (ie, peak oxygen consumption). Secondary endpoints include: (a) Change in cardiac structure and function as assessed by transthoracic echocardiography and cardiac magnetic resonance (MRI imaging), (b) change in biomarkers (ie, CK, CKMB, and NT-proBNP), (c) physical activity, and (d) quality of life. Until December 2019, a total of 41 patients were recruited into the ongoing SILICOFCM study and were allocated to the study groups and the control group. There was no significant difference in key baseline characteristics between the three groups. The SILICOFCM study will provide novel evidence about the effect of sacubitril/valsartan or lifestyle intervention on functional capacity, clinical phenotype, injury and stretch activation markers, physical activity, and quality of life in patients with nonobstructive HCM. © 2020 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.

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