NCT03832660: SILICOFCM

Sacubitril/Valsartan vs Lifestyle in Hypertrophic Cardiomyopathy

Completed Phase 2 Last updated 28 November 2022

What this trial tests

Phase 2 trial testing Lifestyle in Hypertrophic Cardiomyopathy in 168 participants. Completed in 30 June 2022.

Timeline

3 May 2019

Primary endpoint
15 May 2022

30 June 2022

Quick facts

Lead sponsor	Newcastle University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	168
Start date	3 May 2019
Primary completion	15 May 2022
Estimated completion	30 June 2022
Sites	5 locations across Serbia, Italy, United Kingdom, Germany

Drugs / interventions tested

• Lifestyle
• Sacubitril/Valsartan

Conditions studied

• Hypertrophic Cardiomyopathy — all drugs for Hypertrophic Cardiomyopathy →

Sponsor

Newcastle University

Who can join

Adults 18 to 70, any sex, with Hypertrophic Cardiomyopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall aim of this project is to establish potential benefits of a novel lifestyle (physical activity and dietary nitrate) and pharmacological (angiotensin receptor neprilysin inhibitor) interventions in patients with hypertrophic cardiomyopathy (HCM). HCM is the most common genetic cardiovascular disease with a broad spectrum of disease severity. Angiotensin receptor neprilysin inhibitor reduces death, hospitalisation, and may improve cardiac function and exercise tolerance in heart failure. Exercise training is associated with a significant increase in exercise tolerance, but appear to have limited effect on measures of cardiac morphology or function in patients with HCM. Dietary supplementation with inorganic nitrate (i.e. concentrated nitrate-rich beetroot juice) improves exercise capacity, vasodilatation and cardiac output reserves while reduces arterial wave reflections, which are linked to left ventricular diastolic dysfunction and remodelling. Using a five-centre, open label, three-arm, pilot design, the present study will evaluate the effect of lifestyle (physical activity and dietary supplementation with inorganic nitrate) and pharmacological (angiotensin receptor neprilysin inhibitor sacubitril / valsartan) interventions in patients with HCM. The Aim is to examine whether these interventions improve functional capacity, clinical phenotypic characteristics, and quality of life in patients with HCM.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel therapeutics for the treatment of hypertension and its associated complications: peptide- and nonpeptide-based strategies.
   Ghatage T, Goyal SG, Dhar A, Bhat A. · · 2021 · cited 54× · PMID 33731923 · DOI 10.1038/s41440-021-00643-z
2. Genetic determinants of clinical phenotype in hypertrophic cardiomyopathy.
   Velicki L, Jakovljevic DG, Preveden A, Golubovic M, et al · · 2020 · cited 49× · PMID 33297970 · DOI 10.1186/s12872-020-01807-4
3. Pharmacological Management of Hypertrophic Cardiomyopathy: From Bench to Bedside.
   Palandri C, Santini L, Argirò A, Margara F, et al · · 2022 · cited 34× · PMID 35696053 · DOI 10.1007/s40265-022-01728-w
4. Revisiting Diagnosis and Treatment of Hypertrophic Cardiomyopathy: Current Practice and Novel Perspectives.
   Ottaviani A, Mansour D, Molinari LV, Galanti K, et al · · 2023 · cited 20× · PMID 37685777 · DOI 10.3390/jcm12175710
5. Design of the SILICOFCM study: Effect of sacubitril/valsartan vs lifestyle intervention on functional capacity in patients with hypertrophic cardiomyopathy.
   Tafelmeier M, Baessler A, Wagner S, Unsoeld B, et al · · 2020 · cited 13× · PMID 32125709 · DOI 10.1002/clc.23346
6. Pushing the Limits of Medical Management in HCM: A Review of Current Pharmacological Therapy Options.
   Stătescu C, Enachi Ș, Ureche C, Țăpoi L, et al · · 2021 · cited 8× · PMID 34281272 · DOI 10.3390/ijms22137218
7. Narrative review in the current role of angiotensin receptor-neprilysin inhibitors.
   Cruz Rodriguez JB, Cu C, Siddiqui T. · · 2021 · cited 5× · PMID 33850915 · DOI 10.21037/atm-20-4038
8. Subtypes and Mechanisms of Hypertrophic Cardiomyopathy Proposed by Machine Learning Algorithms.
   Glavaški M, Preveden A, Jakovljević Đ, Filipović N, et al · · 2022 · cited 4× · PMID 36294999 · DOI 10.3390/life12101566