Heart failure & cardiomyopathiesSecondary analysis
Impact of Aficamten on Echocardiographic Cardiac Structure and Function in Symptomatic Obstructive Hypertrophic Cardiomyopathy
- Secondary analysis of the SEQUOIA-HCM randomised trial
- phase 3
- multicenter
- double-blinded
- placebo-controlled
Authors' conclusion
Compared with placebo, patients receiving aficamten demonstrated significant improvement in LVOT gradients and measures of LV diastolic function, and several of these measures were associated with improvements in pVO2, KCCQ-CSS, and NT-proBNP. A modest decrease in LVEF occurred yet remained within normal range.
Study context
- Population
- Adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
- Participants
- 282 adults
- Comparison
- Aficamten vs placebo
- Primary endpoint
- Echocardiographic measures of cardiac structure and function
- Follow-up
- 24 weeks
Primary result
As reported in the abstract
Aficamten significantly lowered resting and Valsalva left ventricular outflow (LVOT) gradients and improved left atrial volume index, lateral and septal e' velocities, and lateral and septal E/e'
all P ≤ 0.001
LV end-systolic volume increased and wall thickness decreased
all P ≤ 0.003
Further findings
Association of echocardiographic changes with pVO2, NT-proBNP and Kansas City Cardiomyopathy Questionnaire Clinical Summary Scores (KCCQ-CSS) (aficamten-treated)
- Improved pVO2 and NT-proBNP reduction associated with improvement in lateral e' and septal and lateral E/e'
- all P < 0.03
- KCCQ-CSS improvement associated with decrease in both LVOT gradients
- all P < 0.001
Safety
| Outcome | difference (%) (95% CI) | P value | |
|---|---|---|---|
| LVEF (mild reversible decrease) · 24 weeks | −4.8 (−6.4% to −3.3%) | P < 0.001 | |
| −10−505Difference, % (linear scale) |
| Outcome | difference (%) (95% CI) | P value |
|---|---|---|
| Absolute LV global circumferential strain · 24 weeks | −3.7 (1.8%–5.6%) | P < 0.0010 |
Original publication
Summarised from the published abstract; every number is checked against it