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Mavacamten in Patients With Hypertrophic Cardiomyopathy Referred for Septal Reduction: Week 128 Results From VALOR-HCM

Desai, Milind Y., Wolski, Kathy, Owens, Anjali, Geske, Jeffrey B., Saberi, Sara, Wang, Andrew, Sherrid, Mark, Cremer, Paul C., Lakdawala, Neal K., Tower-Rader, Albree, Fermin, David, Naidu, Srihari S., Smedira, Nicholas G., Schaff, Hartzell, Gong, Zhiqun, Mudarris, Lana, Lampl, Kathy, Sehnert, Amy J., Nissen, Steven E., for the VALOR-HCM Investigators·2025·Circulation
DOI 10.1161/circulationaha.124.072445PMC PMC12063683
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Abstract

BACKGROUND: In severely symptomatic patients with obstructive hypertrophic cardiomyopathy (HCM), VALOR-HCM trial (Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy [URL: https://clinicaltrials.gov ; Unique identifier: NCT04349072]) reported that mavacamten reduced the short-term need for septal reduction therapy (SRT). The current report examined the longer-term effect of mavacamten through end of treatment at week 128. METHODS: A double-blind randomized placebo-controlled multicenter trial at 19 sites in the United States included symptomatic obstructive HCM patients referred for SRT (enrollment July 2020 through October 2021). The group initially randomized to mavacamten continued the drug for 128 weeks and the placebo to mavacamten group from week 16 to 128 (112-week exposure). Dose titrations were performed using echocardiographic left ventricular outflow tract gradient and left ventricular ejection fraction measurements. The principal end point was proportion of patients proceeding with SRT or remaining guideline-eligible at week 128. RESULTS: At week 128, 17 of 108 (15.7%) patients in the total study sample met the composite end point (7 underwent SRT, 1 was SRT-eligible, and 9 SRT-status unevaluable). Additionally, 87 of 108 (80.5%) patients demonstrated ≥1 New York Heart Association class improvement by week 128, and 52 of 108 (48.1%) demonstrated ≥2, with a sustained reduction in resting and Valsalva left ventricular outflow tract gradients of 38.2 mm Hg and 59.4 mm Hg, respectively. Ninety-five of 108 (88%) patients transitioned to commercial mavacamten. Overall, 15 of 108 (13.8%) patients (5.41 per 100 patient-years) had an left ventricular ejection fraction <50% (2 with left ventricular ejection fraction ≤30%; 1 death). Of these, 12 of 15 (80%) continued treatment. New-onset atrial fibrillation occurred in 11 (10.2%) patients (4.55 per 100 patient-years). CONCLUSIONS: In severely symptomatic obstructive HCM patients, sustained freedom from SRT was observed at 128 weeks, with nearly 90% patients remaining on long-term mavacamten. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04349072.

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Figure 1. Primary and key efficacy parameters from baseline to week 128 in VALOR-HCM trial. A, Primary composite end point from baseline to week 128. B, Improvement in New York Heart Association (NYHA) class from baseline to week 128. SRT indicates septal reduction therapy; and VALOR-HCM, Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy.
Figure 1. Primary and key efficacy parameters from baseline to week 128 in VALOR-HCM trial. A, Primary composite end point from baseline to week 128. B, Improvement in New York Heart Association (NYHA) class from baseline to week 128. SRT indicates septal reduction therapy; and VALOR-HCM, Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy.CC BY · PubMed Central
Figure 2. Key echocardiographic efficacy and safety parameters from baseline to week 128 for the original mavacamten and the placebo to mavacamten groups. A, Change in left ventricular (LV) ejection fraction. B, Improvement in peak left ventricular outflow tract (LVOT) gradient at rest. C, Improvement in peak left ventricular outflow tract gradient after Valsalva maneuver. D, Improvement in peak left ventricular outflow tract gradient after stress echocardiography. Plotted values in B through D represent means and standard errors.
Figure 2. Key echocardiographic efficacy and safety parameters from baseline to week 128 for the original mavacamten and the placebo to mavacamten groups. A, Change in left ventricular (LV) ejection fraction. B, Improvement in peak left ventricular outflow tract (LVOT) gradient at rest. C, Improvement in peak left ventricular outflow tract gradient after Valsalva maneuver. D, Improvement in peak left ventricular outflow tract gradient after stress echocardiography. Plotted values in B through D represent means and standard errors.CC BY · PubMed Central
Figure 3. Additional echocardiographic parameters from baseline to week 128 demonstrating favorable cardiac remodeling for the original mavacamten and the placebo to mavacamten groups. A, Improvement interventricular wall thickness. B, Improvement in left ventricular mass index. C, Improvement in left atrial volume index. D, Improvement in E/e’. Plotted values in B through D represent means and standard errors.
Figure 3. Additional echocardiographic parameters from baseline to week 128 demonstrating favorable cardiac remodeling for the original mavacamten and the placebo to mavacamten groups. A, Improvement interventricular wall thickness. B, Improvement in left ventricular mass index. C, Improvement in left atrial volume index. D, Improvement in E/e’. Plotted values in B through D represent means and standard errors.CC BY · PubMed Central
Figure 4. Changes in biomarkers and health status from baseline to week 128 demonstrating favorable cardiac remodeling for the original mavacamten and the placebo to mavacamten. A, Improvement in Kansas City Cardiomyopathy Questionnaire 23-Item Clinical Summary Score (KCCQ-23 CSS). B, Improvement NT-pro-BNP (N-terminal pro brain natriuretic peptide). C, Improvement in cTn-I (troponin I).
Figure 4. Changes in biomarkers and health status from baseline to week 128 demonstrating favorable cardiac remodeling for the original mavacamten and the placebo to mavacamten. A, Improvement in Kansas City Cardiomyopathy Questionnaire 23-Item Clinical Summary Score (KCCQ-23 CSS). B, Improvement NT-pro-BNP (N-terminal pro brain natriuretic peptide). C, Improvement in cTn-I (troponin I).CC BY · PubMed Central

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Metadata

Authors
Desai, M. Y., Wolski, K., Owens, A., Geske, J. B., Saberi, S., Wang, A., Sherrid, M., Cremer, P. C., Lakdawala, N. K., Tower-Rader, A., Fermin, D., Naidu, S. S., Smedira, N. G., Schaff, H., Gong, Z., Mudarris, L., Lampl, K., Sehnert, A. J., Nissen, S. E., & for the VALOR-HCM Investigators
Venue
Circulation
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2025-05-13
Volume
151
Issue
19
Pages
1378-1390
ISSN
  • 0009-7322
  • 1524-4539
DOI
10.1161/circulationaha.124.072445
PMC
PMC12063683
Cited by
78
References
1
Language
en
Update notices
correction (2025-05-12)
Licence
creativecommons.org/licenses/by/4.0/ (tdm)
Funders
Bristol Myers Squibb Foundation

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CoChat. (2026). Citation check: Mavacamten in Patients With Hypertrophic Cardiomyopathy Referred for Septal Reduction: Week 128 Results From VALOR-HCM. https://app.cochat.ai/papers/10.1161/circulationaha.124.072445
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Desai, M. Y., Wolski, K., Owens, A., Geske, J. B., Saberi, S., Wang, A., Sherrid, M., Cremer, P. C., Lakdawala, N. K., Tower-Rader, A., Fermin, D., Naidu, S. S., Smedira, N. G., Schaff, H., Gong, Z., Mudarris, L., Lampl, K., Sehnert, A. J., Nissen, S. E., & for the VALOR-HCM Investigators. (2025). Mavacamten in Patients With Hypertrophic Cardiomyopathy Referred for Septal Reduction: Week 128 Results From VALOR-HCM. Circulation. https://doi.org/10.1161/circulationaha.124.072445