Open AccessDesign of the SILICOFCM study: Effect of sacubitril/valsartan vs lifestyle intervention on functional capacity in patients with hypertrophic cardiomyopathy
Author(s) -
Tafelmeier Maria,
Baessler Andrea,
Wagner Stefan,
Unsoeld Bernhard,
Preveden Andrej,
Barlocco Fausto,
Tomberli Alessia,
Popovic Dejana,
Brennan Paul,
MacGowan Guy A.,
Ristic Arsen,
Velicki Lazar,
Olivotto Iacopo,
Jakovljevic Djordje G.,
Maier Lars S.
Publication year - 2020
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.23346
Subject(s) - medicine , valsartan , ejection fraction , cardiology , heart failure , sacubitril , clinical endpoint , hypertrophic cardiomyopathy , cardiomyopathy , sacubitril, valsartan , cardiac magnetic resonance imaging , randomized controlled trial , blood pressure , magnetic resonance imaging , radiology
Abstract Background 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. Hypothesis 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). Methods 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. Results 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. Conclusion 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.