Tafelmeier, Maria and Baessler, Andrea and Wagner, Stefan and Unsoeld, Bernhard and Preveden, Andrej and Barlocco, Fausto and Tomberli, Alessia and Popovic, Dejana and Brennan, Paul and MacGowan, Guy A. and Ristic, Arsen and Velicki, Lazar and Olivotto, Iacopo and Jakovljevic, Djordje G. and Maier, Lars S. (2020) Design of the SILICOFCM study: Effect of sacubitril/valsartan vs lifestyle intervention on functional capacity in patients with hypertrophic cardiomyopathy. CLINICAL CARDIOLOGY, 43 (5). pp. 430-440. ISSN 0160-9289, 1932-8737
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | NEPRILYSIN INHIBITOR LCZ696; HEART-FAILURE; PHYSICAL-ACTIVITY; INORGANIC NITRATE; TASK-FORCE; RECOMMENDATIONS; PARTICIPATION; GUIDELINES; MANAGEMENT; PHYSIOLOGY; familial cardiomyopathy; HCM; hereditary cardiac disease; left ventricular hypertrophy |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 29 Mar 2021 09:27 |
| Last Modified: | 29 Mar 2021 09:27 |
| URI: | https://pred.uni-regensburg.de/id/eprint/44964 |
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