LEAF‑HCM: What can we learn from the early use of aficamten in people who have no symptoms but do have a thickened heart muscle with blood flow obstruction?
Learning From Early Aficamten In HCM (LEAF-HCM)
interventional
N/A
1 country
1
To evaluate the effect of aficamten vs placebo on post-Valsalva left ventricular outflow tract gradients (LVOT-G) in patients with asymptomatic oHCM
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 13, 2026
Actual (reported)Change in post-Valsalva LVOT-G from baseline to Week 54
Change in LAVI, maximal LV wall thickness, LV mass index, LGE percentage by cMRI from baseline to Week 54
Change in SUV by FAPI-PET/CT scan from base-line to Week 54
Change from baseline to Week 54 in echocar-diographic measurements of cardiac structure and of systolic function including: • Left ventricular ejection fraction • Left ventricular end-systolic and end-diastolic volumes (LVESV and LVEDV, re-spectively) • Left atrial volume
Change in biomarkers (NT-proBNP, hsTnT) from baseline to Week 18 and Week 54
Assessed by analysing change in incidence of heart failure, as defined by: • Change in NYHA class to NYHA class 2 or higher at week 18 and Week 54. • Incidence of an official diagnosis of heart failure during the study (at week 54). • Incidence of indicators that correspond with disease progression, such as: atrial fibrillation, indication for septal reduction therapy, ventricular arrhythmias, death.
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Formulated product
MYQORZO 5 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
MYQORZO 5 mg film-coated tablets
Named ingredient: aficamten
View registry recordErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, 3015 GD, Netherlands
P.P.M. Zwetsloot
First Submitted
July 13, 2026
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
A Comparison of Two Treatments: Pacemaker and Percutaneous Transluminal Septal Ablation for Hypertrophic Cardiomyopathy
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