This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
5-20mg
Beijing Anzhen Hospital
Beijing, China
Beijing Chao-yang Hospital, Capital Medical University
Beijing, China
Fuwai Hospital, CAMS & PUMC
Beijing, China
Patient incidence of reported adverse events (AEs)
Time frame: Baseline to End of study, up to 2 years
Patient incidence of reported serious adverse events (SAEs )
Time frame: Baseline to End of study, up to 2 years
Patient incidence of LVEF<50% & LVEF <40%
Time frame: Baseline to End of study, up to 2 years
Peak LVOT-G at rest and with Valsalva provocation
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with resting LVOT-G <50 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with resting LVOT-G <30 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with post-Valsalva LVOT-G <50 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with post-Valsalva LVOT-G <30 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
First resting LVOT-G <50 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.
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Peking University Third Hospital
Beijing, China
Sichuan Provincial People's Hospital
Chengdu, China
Nanfang Hospital
Guangzhou, China
The Second Affiliated Hospital of Nanchang University
Jiangxi, China
The First Hospital of Jilin University
Jilin, China
Shengjing Hospital of China Medical University
Shenyang, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
...and 2 more locations
First resting LVOT-G <30 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.
First post-Valsalva LVOT-G <50 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.
First post-Valsalva LVOT-G <30 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.
First LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.