Heart failure & cardiomyopathies

Safety and Efficacy of Aficamten in Patients with Non-Obstructive Hypertrophic Cardiomyopathy: A 36-Week Analysis from FOREST-HCM

Eur J Heart FailPublished Open-label single-arm trial

Authors' conclusion

Over 36 weeks, aficamten appeared safe and effective in the studied patients with nHCM.

Study context

Population
Patients with non-obstructive hypertrophic cardiomyopathy (nHCM); mean age 57.2 ± 15.3 years, 62% female, 41% NYHA class III
Participants
34 patients
Outcome
Safety and efficacy
Follow-up
36 weeks
Methodological details36-week analysis of the ongoing FOREST-HCM trial, left ventricular ejection fraction (LVEF)-guided dose titration
  • 36-week analysis of the ongoing FOREST-HCM trial
  • LVEF-guided dose titration

Main finding

As reported in the abstract

Achieved 15-20 mg daily dose
82.3%
Change in LVEF from 70% ± 6.1 (p < 0.0001)
−4.3% ± 5.2
NYHA class improved by ≥1 class at Week 36, n (%)
27 (79.4%)
Mean change in KCCQ clinical summary score vs baseline (points)
13.8 ± 12.5
Median (IQR) change in NT-proBNP from baseline (p < 0.0001)
−665.5 pg/ml [−1244.0, −232.0]
Median (IQR) change in hs-cTnI, unchanged (p = 0.25)
−2.7 ng/L [−11.3, 1.6]

Safety

Drug discontinuations due to AEs · 36 weeks

No drug discontinuations due to adverse events

LVEF <50% · 36 weeks

LVEF <50% occurred in 2 patients (one following pulmonary vein isolation, one associated with AF)
5.9%

Change in LVEF · 36 weeks

Modest reduction in LVEF from 70% ± 6.1 (mean ± SD)
−4.3% ± 5.2 (p < 0.0001)

Original publication

Safety and Efficacy of Aficamten in Patients with Non-Obstructive Hypertrophic Cardiomyopathy: A 36-Week Analysis from FOREST-HCM. Eur J Heart Fail. Published 18 July 2024. doi:10.1002/ejhf.3372

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