Exercise Capacity in Patients With Obstructive Hypertrophic Cardiomyopathy: SEQUOIA-HCM Baseline Characteristics and Study Design
Language English Country United States Media print-electronic
Document type Journal Article, Review, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
Grant support
CH/1992001/6764
British Heart Foundation - United Kingdom
R01 HL151841
NHLBI NIH HHS - United States
R01 HL131029
NHLBI NIH HHS - United States
R01 HL159514
NHLBI NIH HHS - United States
PubMed
38032573
DOI
10.1016/j.jchf.2023.10.004
PII: S2213-1779(23)00689-3
Knihovny.cz E-resources
- Keywords
- aficamten, drug therapy, obstructive hypertrophic cardiomyopathy, randomized controlled trial,
- MeSH
- Cardiomyopathy, Hypertrophic * complications MeSH
- Quality of Life MeSH
- Humans MeSH
- Sequoia * MeSH
- Heart Failure * drug therapy MeSH
- Exercise Tolerance MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Review MeSH
- Research Support, N.I.H., Extramural MeSH
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).
Beijing Anzhen Hospital Capital Medical University Beijing China
Charité Campus Virchow Klinikum Berlin Germany
Cytokinetics Incorporated South San Francisco California USA
Erasmus University Medical Center Rotterdam the Netherlands
Hospital Da Luz Lisbon Portugal
Hypertrophic Cardiomyopathy Center at Lahey Medical Center Burlington Massachusetts USA
Leviev Heart Center Sheba Medical Center Israel; Tel Aviv University Medical School Israel
Massachusetts General Hospital Boston Masachusetts USA
Meyer Children's Hospital Istituto di Ricovero e Cura a Carattere Scientifico Florence Italy
Narodowy Instytut Kardiologii Warsaw Poland
Northwestern University Feinberg School of Medicine Chicago Illinois USA
Oregon Health and Science University Portland Oregon USA
Radcliffe Department of Medicine University of Oxford Oxford United Kingdom
School of Cardiovascular and Metabolic Health University of Glasgow Glasgow United Kingdom
UCSF Medical Center San Francisco California USA
University Hospital Motol and 2nd Medical School Charles University Prague Czech Republic
References provided by Crossref.org
ClinicalTrials.gov
NCT05186818
