Symptomatic hypertrophic cardiomyopathy (HCM)
Conditions
Brief summary
1. Patient incidence of reported adverse events (AEs), 2. Patient incidence of reported serious adverse events (SAEs), 3. Patient incidence of left ventricular ejection fraction (LVEF) <50%
Detailed description
1. Change from baseline values through end of participation in: − Peak LVOT-G at rest and with Valsalva provocation − Proportion of patients with resting LVOT-G <30 mmHg − Proportion of patients with post-Valsalva LVOT-G <50 mmHg − Proportion of patients with post-Valsalva LVOT-G <30 mmHg − Proportion of patients with LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg, 2. Time to the following event through last follow-up - First resting LVOT-G <30 mmHg − First post-Valsalva LVOT-G <50 mmHg − First post-Valsalva LVOT-G <30 mmHg − First LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg
Interventions
DRUGAficamten
Sponsors
Cytokinetics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient incidence of reported adverse events (AEs), 2. Patient incidence of reported serious adverse events (SAEs), 3. Patient incidence of left ventricular ejection fraction (LVEF) <50% | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline values through end of participation in: − Peak LVOT-G at rest and with Valsalva provocation − Proportion of patients with resting LVOT-G <30 mmHg − Proportion of patients with post-Valsalva LVOT-G <50 mmHg − Proportion of patients with post-Valsalva LVOT-G <30 mmHg − Proportion of patients with LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg, 2. Time to the following event through last follow-up - First resting LVOT-G <30 mmHg − First post-Valsalva LVOT-G <50 mmHg − First post-Valsalva LVOT-G <30 mmHg − First LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg | — |
Countries
Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed