Heart failure & cardiomyopathies
Sacubitril/Valsartan for the Treatment of Non-Obstructive Hypertrophic Cardiomyopathy: An Open Label Randomized Controlled Trial (SILICOFCM)
Authors' conclusion
In patients with HCM, a 16-week treatment with sacubitril/valsartan was well tolerated but had no effect on exercise capacity, cardiac structure, or function.
Study context
- Population
- Adults with symptomatic non-obstructive hypertrophic cardiomyopathy (HCM) (NYHA class I–III)354 screened
- Participants
- 115 adults
- Comparison
- Sacubitril/valsartan vs control
- Sacubitril/valsartann = 79
- Controln = 36reference
- Primary endpoint
- Change in peak VO2
- Follow-up
- 16 weeks
Methodological detailsphase II, open-label, multicentre, 2:1 randomisation, Enrolment May 2018 to October 2021
- Phase II
- Open-label
- Multicentre
- 2:1 randomisation
- Enrolment May 2018 to October 2021
Primary result
As reported in the abstract
Peak VO2, change from baseline
Sacubitril/valsartan: no significant change from baseline (15.3 [4.3] vs 15.9 [4.3] ml/kg/min)
p = 0.13
Control: no significant change from baseline
p = 0.47
Secondary outcomes
BP, cardiac structure and function, plasma biomarkers, quality of life
- No clinically significant changes
Original publication
Sacubitril/Valsartan for the Treatment of Non-Obstructive Hypertrophic Cardiomyopathy: An Open Label Randomized Controlled Trial (SILICOFCM). Eur J Heart Fail. Published 27 May 2024. doi:10.
Summarised from the published abstract; every number is checked against it