JACC. Heart failure · 2023
Exercise Capacity in Patients With Obstructive Hypertrophic Cardiomyopathy: SEQUOIA-HCM Baseline Characteristics and Study Design.
СтатьяОбзорПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Coats Caroline J, Maron Martin S, Abraham Theodore P, Olivotto Iacopo, Lee Matthew M Y, Arad Michael, Cardim Nuno, Ma Chang-Sheng, Choudhury Lubna, Düngen Hans-Dirk, Garcia-Pavia Pablo, Hagège Albert A, Lewis Gregory D, Michels Michelle, Oreziak Artur, Owens Anjali T, Tfelt-Hansen Jacob, Veselka Josef, Watkins Hugh C, Heitner Stephen B, Jacoby Daniel L, Kupfer Stuart, Malik Fady I, Meng Lisa, Wohltman Amy, Masri Ahmad, SEQUOIA-HCM Investigators
Аннотация
Patients with obstructive hypertrophic cardiomyopathy (oHCM) have increased risk of arrhythmia, stroke, heart failure, and sudden death. Contemporary management of oHCM has decreased annual hospitalization and mortality rates, yet patients have worsening health-related quality of life due to impaired exercise capacity and persistent residual symptoms. Here we consider the design of clinical trials evaluating potential oHCM therapies in the context of SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM). This large, phase 3 trial is now fully enrolled (N = 282). Baseline characteristics reflect an ethnically diverse population with characteristics typical of patients encountered clinically with substantial functional and symptom burden. The study will assess the effect of aficamten vs placebo, in addition to standard-of-care medications, on functional capacity and symptoms over 24 weeks. Future clinical trials could model the approach in SEQUOIA-HCM to evaluate the effect of potential therapies on the burden of oHCM. (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM [SEQUOIA-HCM]; NCT05186818).