About this trial
This multicenter, prospective, observational, real-world clinical study aims to evaluate the efficacy and safety of Aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) by prospectively observing changes in symptoms, biomarkers, imaging findings, and adverse reactions, etc. It will also record the dosing regimens at which individual patients achieve steady state, and explore the treatment patterns of Aficamten in Chinese patients with symptomatic nHCM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-85 years.
Left ventricular wall thickness ≥15 mm at any site on echocardiography or cardiac magnetic resonance.
Left ventricular wall thickness ≥13 mm in individuals testing positive for a pathogenic variant or in genetically affected family members.
Ventricular wall thickening caused by other cardiovascular diseases or systemic or metabolic disorders has been excluded.
Disqualifiers
LVOTG ≥30 mmHg at rest and/or with provocation.
LVEF <50% on transthoracic echocardiography.
Symptomatic hypotension or systolic blood pressure (SBP) <100 mmHg.
Severe renal impairment, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or currently receiving blood purification therapy.
Trial population
Patients with symptomatic non-obstructive hypertrophic cardiomyopathy
Trial design
Cohort
Prospective
Treatments tested in this trial
receiving aficamten
DrugAficamten will be administered at a specified dose according to each patient's tolerability, as assessed by echocardiography.
Treatment groups
Trial outcomes
Primary outcomes
Percentage change from baseline in NT-proBNP and/or absolute change from baseline in KCCQ-CSS
Secondary outcomes
Absolute change from baseline in NT-proBNP
Percentage change from baseline in TnT/TnI
Absolute change from baseline in TnT/TnI
Absolute change from baseline in maximal wall thickness (MWT)
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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