Heart failure & cardiomyopathiesRandomised controlled trial
Mavacamten in Patients With Hypertrophic Cardiomyopathy Referred for Septal Reduction: Week 128 Results From VALOR-HCM
- Randomised controlled trial (long-term extension of VALOR-HCM)
- double-blind
- placebo-controlled
- multicentre
- 19 US sites
Authors' conclusion
In severely symptomatic obstructive HCM patients, sustained freedom from SRT was observed at 128 weeks, with nearly 90% patients remaining on long-term mavacamten.
Study context
- Population
- Symptomatic obstructive hypertrophic cardiomyopathy (HCM) patients referred for septal reduction therapy (SRT)
- Participants
- 108 patients
- Comparison
- Mavacamten vs placebo to mavacamten
- Primary endpoint
- Proportion proceeding with SRT or remaining guideline-eligible
- Follow-up
- Week 128
Primary result
As reported in the abstract
Proceeded with SRT or remained SRT-eligible (total study sample)
Met composite end point (7 underwent SRT, 1 SRT-eligible, 9 SRT-status unevaluable)
17 of 108 (15.7%)
Further findings
NYHA class improvement · week 128
- ≥1 NYHA class improvement
- 87 of 108 (80.5%)
- ≥2 NYHA class improvement
- 52 of 108 (48.1%)
LV outflow tract gradient
mm Hg
- Sustained reduction in resting gradient
- 38.2
- Sustained reduction in Valsalva gradient
- 59.4
Transition to commercial mavacamten
- Transitioned to commercial mavacamten
- 95 of 108 (88%)
Safety
LVEF <50%
- LVEF <50%
- 15 of 108 (13.8%)
- Rate
- 5.41 per 100 patient-years
- LVEF ≤30%
- 2
- Death
- 1
- Continued treatment
- 12 of 15 (80%)
New-onset AF
- New-onset AF
- 11 (10.2%)
- Rate
- 4.55 per 100 patient-years
Original publication
Mavacamten in Patients With Hypertrophic Cardiomyopathy Referred for Septal Reduction: Week 128 Results From VALOR-HCM. Circulation. Published 18 November 2024. doi:10.1161/circulationaha.124.072445
Summarised from the published abstract; every number is checked against it