A small-molecule modulator of cardiac myosin acts on multiple stages of the myosin chemomechanical cycle. Identify and review the mechanism of action of mavacamten. We thank Eduard Quintana and colleagues for their Correspondence. Lastly, the safety data from EXPLORER-HCM will be aggregated with the ongoing PIONEER-OLE and MAVA-LTE extension studies to gain the maximal possible experience regarding the safety of mavacamten. The results of the global, phase 3 EXPLORER-HCM trial were presented at the European Society of Cardiology (ESC) Congress 2020 and simultaneously published in The Lancet. Customer Service Effects of Sarcomere Activators and Inhibitors Targeting Myosin Cross-Bridges on Ca. 2014 ESC guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): health status analysis of a randomized, double-blind, placebo-controlled, phase 3 trial. https://doi.org/10.1161/CIRCHEARTFAILURE.120.006853, National Center Reaney M, Addepalli P, Allen V, Spertus JA, Dolan C, Sehnert AJ, Fine JT. Don't Miss a Beat as Drs. Septal myotomy-myectomy and transcoronary septal alcohol ablation in hypertrophic obstructive cardiomyopathy. Energetic drain driving hypertrophic cardiomyopathy. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. At baseline, all subjects were NYHA Class II or III. Assuming that a similar percentage of EXPLORER-HCM participants in the active treatment arm and 25% in placebo arm will achieve the primary end point at the end of 30-week dosing period, the sample size of 110 participants per arm will provide 96% power at 2-sided 5% statistical significance level. Epub 2020 Aug 29. Treatment with mavacamten showed sustained improvement in left ventricular outflow tract (LVOT) gradients, New York Heart Association (NYHA) Class and N-terminal pro brain natriuretic peptide (NT-proBNP) levels At 48 and 84 Weeks, Mavacamten safety was consistent with that seen in the EXPLORER-HCM study Interim results were presented as a late-breaking clinical trial at the American College of . A systematic review and meta-analysis of long-term outcomes after septal reduction therapy in patients with hypertrophic cardiomyopathy. Karola Marcinkowskiego, Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Hospital Universitario Virgen de La Arrixaca, Hospital Universitario Puerta de Hierro - Majadahonda, Cardiff, South Glamergon, United Kingdom, CF14 4XW. MyoKardia announced positive 12- and 24-week safety, efficacy and biomarker data from the PIONEER-HCM trial in early March. Is heart failure with preserved ejection fraction a dementia of the heart? . EXPLORER-CN will enroll approximately 81 patients. Unable to load your collection due to an error, Unable to load your delegates due to an error. Mavacamten Treatment for Obstructive Hypertrophic Cardiomyopathy: A Clinical Trial. Cardiac rhythm monitoring with 48-hour Holter is performed at the beginning, middle, and end of treatment. Based on data from the EXPLORER-HCM study, the company has a PDUFA date in the U.S. of April 28, 2022. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Symptomatic, left ventricular outflow tract gradient, Percentage of Participants Achieving A Clinical Response [TimeFrame:30 weeks], Changes From Baseline to Week 30 in Post Exercise in LVOT Peak Gradient. Randomization was stratified by NYHA functional class (II or III), current treatment with -blocker (yes or no), type of ergometer (treadmill or exercise bicycle), and consent for the CMR substudy (yes or no). 2020;13:e006853. The following safety end points are adjudicated by the Clinical Event Adjudication Committee: death, stroke, acute myocardial infarction, all hospitalizations (cardiovascular and noncardiovascular), HF events (includes HF hospitalizations and emergency room/urgent outpatient visits for HF), atrial fibrillation/flutter (new from screening), implantable cardioverter-defibrillator therapy, resuscitated cardiac arrest, ventricular tachyarrhythmias (includes ventricular tachycardia and ventricular fibrillation). Lancet. Oral - 288. 2022 Aug 18;9:949294. doi: 10.3389/fcvm.2022.949294. 10:06 AM - 10:16 AM . Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Dr Wang reports grants from MyoKardia, Inc, and honoraria from Cytokinetics. Lancet. Genotype and lifetime burden of disease in hypertrophic cardiomyopathy: insights from the sarcomeric human cardiomyopathy registry (SHaRe). Mavacamten is being 2020 Sep 12;396(10253):759-769. doi: 10.1016/S0140-6736(20)31792-X. Change in resting LVOT gradient from baseline to 84 weeks: -32.8 mm Hg, Change in Valsalva LVOT gradient from baseline to 84 weeks: -46.4 mm Hg, Change in LVEF from baseline to 84 weeks: -9%, Change in N-terminal proB-type natriuretic peptide from baseline to 84 weeks: -488 ng/L, with no significant long-term treatment-related adverse events, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Pulmonary Hypertension and Venous Thromboembolism, ACC Anywhere The ACC.22 Meeting on Demand Program, CardioSource Plus for Institutions and Practices, Annual Scientific Session and Related Events, ACC Quality Improvement for Institutions Program, National Cardiovascular Data Registry (NCDR), Efficacy, Safety of Mavacamten in Treating Obstructive HCM Holds Up in EXPLORER-LTE Cohort of MAVA-LTE Study, Online Course: HCM: Accelerating Guideline-Driven Care, JACC Interactive Tool: Genetic Testing and Family Screening, CardioSmart For Your Patients: HCM Discussion Guide, Guideline Hub | Hypertrophic Cardiomyopathy, Heart Failure and Cardiomyopathies Clinical Topic Collection, Cardiacasts PulseCheck: Invasive Treatment Options for Heart Failure, Left Ventricular Activation Time Shortening With Conduction System Pacing vs Biventricular Resynchronization Therapy, Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation, Dapagliflozin and Cause-Specific Mortality in HF Across Spectrum of EF, A Deep Patient-Similarity Learning Framework For Age-Invariant Recognition of Diastolic Dysfunction in Elderly Patients, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Pulmonary Hypertension and Venous Thromboembolism, Hypertrophic obstructive cardiomyopathy (left ventricular outflow tract [LVOT] gradient 50 mm Hg), New York Heart Association (NYHA) class II-III symptoms, Sustained ventricular tachycardia with exercise within 6 months, Post-exercise LVOT gradient change from baseline to week 30: -47 mm Hg in the mavacamten group vs. -10 mm Hg in the placebo group (p < 0.0001), Change in LVEF: -6.6% in the mavacamten group vs. -0.3% in the placebo group (p = 0.0025), At 30 weeks, change in KCCQ-overall summary score: 14.9 for mavacamten vs. 5.4 for placebo (difference +9.1, p < 0.0001). Effect of Mavacamten on Systolic Anterior Motion of the Mitral Valve and Mitral Regurgitation in Patients with Obstructive Hypertrophic Cardiomyopathy: Insights from the VALOR . EXPLORER-LTE enrolled 231 of the 244 patients who were eligible for the long-term extension study at the end of EXPLORER-HCM. 2+ It's actually this first-in-class myo-blocker, that is a selective allosteric inhibitor of the cardiac myosin ATPase. Efficacy of ranolazine in patients with symptomatic hypertrophic cardiomyopathy: the RESTYLE-HCM randomized, double-blind, placebo-controlled study. Outline the indications for mavacamten. TEMPO: A phase 2, double-blind, randomized, placebo-controlled, dose ranging, parallel group study to evaluate the effect of eleclazine on ventricular arrhythmia in subjects with implantable cardioverter-defibrillator or cardiac resynchronization therapy-defibrillator. Insights from the EXPLORER-HCM Trial Arnold, S Oral - 288. A plain language summary of the EXPLORER-HCM study: mavacamten for obstructive hypertrophic cardiomyopathy. Published data in HF and HCM,2224 analyses of the Sarcomeric Human Cardiomyopathy Registry (SHaRe) cohort,21 and insights from the phase 2 PIONEER-HCM trial18 informed the selection of the primary end point for EXPLORER-HCM as a responder analysis, comprised of changes of pVO2 and NYHA functional class. Clinical profile of nonresponders to surgical myectomy with obstructive hypertrophic cardiomyopathy. An array of secondary and exploratory end points will further dissect out the finer details regarding the effect of mavacamten on oHCM, including symptoms, functional capacity, LVOT gradient, serum biomarkers of myocardial injury and hemodynamic stress, and cardiac structure. For mixed model repeated measure analyses, missing data are handled by the model implicitly. Xie J, Wang Y, Xu Y, Fine JT, Lam J, Garrison LP. MAVA-LTE was designed with the intent of providing more data from a long-term perspective related to the effects of mavacamten on than the phase 3 EXPLORER-HCM trial. The results of this pivotal trial highlight the benefits of disease-specific treatment Mavacamten had a good safety profile with 97% completion through 30 weeks and no increase in overall adverse events compared to the placebo during the trial. The EXPLORER-HCM trial showed that mavacamten was superior to placebo at improving exercise capacity and health status. Positive data for mavacamten, former MyoKardia lead asset. November 1, 2022 - 4:05 pm. Effect of Mavacamten on Systolic Anterior Motion of the Mitral Valve and Mitral Regurgitation in Patients with Obstructive Hypertrophic Cardiomyopathy: Insights from the VALOR-HCM . eCollection 2022. The EXPLORER-HCM trial showed that mavacamten was superior to placebo at improving exercise capacity and health status. The Data Supplement is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCHEARTFAILURE.120.006853. 8600 Rockville Pike Significant mitral regurgitation (MR) is frequent in patients with hypertrophic cardiomyopathy (HCM) either obstructive or non-obstructive. SAS Version 9.4 or higher will be used for statistical analyses. Improving symptom burden and functional capacity are critical objectives and a major unmet need in a disease characterized by relatively low mortality but substantial impact on daily activities and well-being. Epub 2021 May 24. Cardiac output and cardiopulmonary responses to exercise in heart failure: application of a new bio-reactance device. Impact of Mavacamten on Artificial Intelligence Electrocardiographic Diagnosis of Hypertrophic Cardiomyopathy in the EXPLORER-HCM Trial Siontis, K Poster - SA2182 Notably, six patients on mavacamten had transient decrease in LVEF of < 50% not attributed to other causes, though not associated with clinical adverse outcomes. Combined measurements of cardiac troponin I and brain natriuretic peptide are useful for predicting adverse outcomes in hypertrophic cardiomyopathy. 3 EXPLORER-HCM (Clinical Study to Evaluate Mavacamten [MYK-461] in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy) trial.3,4 The cardiac magnetic resonance (CMR) imaging substudy examined the effect of mavacamten versus placebo on cardiac structure and function. Conclusions: EXPLORER-HCM is a phase 3 trial in oHCM testing a first-in-class, targeted strategy of myosin inhibition to improve symptom burden and exercise capacity through reducing LV outflow tract obstruction. By involving a patient representative in our Steering Committee to specifically advise on the patient perspective, we hope to have incorporated aspects of study design that clinicians and scientists cannot achieve in isolation. Study Design Randomized Parallel Double-blind Placebo o LIBRA trial designed to support registration in China o Topline results expected in the fourth quarter of 2023. oHCM is a highly dynamic condition, often with day-to-day variability in symptoms.1,2 This, compounded by the relatively low event rates seen in HCM, has resulted in challenges with the traditional single end point approach used in clinical trials. Pharmacological treatment currently comprises non-disease specific therapies such as blockers, negatively inotropic calcium channel blockers, and disopyramide, which offer a variable degree of symptomatic relief and are often limited by side-effects. A position paper from the Heart Failure Association (HFA) and the Working Group on Myocardial Function of the European Society of Cardiology (ESC), Validation of the Kansas City Cardiomyopathy Questionnaire in Symptomatic Obstructive HypertrophicCardiomyopathy, Mavacamten for hypertrophic cardiomyopathy: effectiveness and value, Targeting the sarcomere in inherited cardiomyopathies, Effects of Sarcomere Activators and Inhibitors Targeting Myosin Cross-Bridges on Ca Change from baseline was determined as per the study statistical analysis plan and compared between treatment arms. Mavacamten Favorably Impacts Cardiac Structure in Obstructive Hypertrophic Cardiomyopathy, Hypertrophic Cardiomyopathy: Updates Through the Lens of Sports Cardiology, 2020 AHA/ACC guideline for the diagnosis and treatment of patients with hypertrophic cardiomyopathy, Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): health status analysis of a randomised, double-blind, placebo-controlled, phase 3 trial, Effect of Mavacamten on Echocardiographic Features in Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy, Randomized Trial of Metoprolol in Patients With Obstructive HypertrophicCardiomyopathy, Exosomally derived Y RNA fragment alleviates hypertrophic cardiomyopathy in transgenic mice, 2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy, Modelling genetic diseases for drug development: Hypertrophic cardiomyopathy, Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial, Quality of life status determinants in hypertrophic cardiomyopathy as evaluated by the Kansas City Cardiomyopathy Questionnaire, Small Molecules Acting on Myofilaments as Treatments for Heart and Skeletal Muscle Diseases, Longitudinal Psychometric Analysis of the Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ) Using Outcomes from the Phase III EXPLORER-HCM Trial, Development of the Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ): A New Patient-Reported Outcome (PRO) Instrument, Pushing the Limits of Medical Management in HCM: A Review of Current Pharmacological Therapy Options, Clinical response defined as achieving: (1) an improvement of 1.5 mL/kg/min or more in pVO, Proportion of patients with at least 1 class improvement in NYHA functional class from baseline to week 30, Patient-reported health-related quality of life as assessed by the KCCQ score, Patient-reported severity of HCM symptoms as assessed by the HCMSQ shortness of breath subscore, Postexercise LVOT peak gradient <50 mmHg or <30 mmHg at week 30, Echocardiographic indices of cardiac structure (LV wall thickness) as well as systolic and diastolic function, Cardiac biomarkers (NT-proBNP, hs-cardiac-troponin-I), Daily step count and other accelerometer parameters, Major adverse cardiac events (death, stroke, acute myocardial infarction), Hospitalizations (both CV and non-CV) and HF events, ICD therapy and resuscitated cardiac arrest, Ventricular tachyarrhythmias (includes VT, VF, and torsades de pointes), Frequency and severity of treatment-emergent adverse events and serious adverse events, and laboratory abnormalities (including trends in NT-proBNP), Change from baseline to week 30 in LV mass index, Change from baseline to week 30 in myocardial fibrosis as measured by late gadolinium enhancement, Changes from baseline to week 30 in cellular hypertrophy, left atrial volume and function, and LV function. Genotype and lifetime burden of disease in hypertrophic cardiomyopathy: insights from the Sarcomeric Human Cardiomyopathy Registry (SHaRe). Meta-analysis of symptomatic response attributable to the pacing component of cardiac resynchronization therapy. Dr Roe reports grants and honoraria from Sanofi Aventis, AstraZeneca, and Amgen, honoraria from Janssen Pharmaceuticals, Elsevier Publishers, Regeneron, Roche-Genentech, Eli Lilly, Novo Nordisk, Pfizer, and Signal Path, and grants from Ferring Pharmaceuticals, MyoKardia, Inc, American College of Cardiology, American Heart Association, Familial Hypercholesterolemia Foundation, Patient-Centered Outcomes Research Institute, and Bayer Pharmaceuticals. This study was supported by MyoKardia, Inc. Dr Ho has served as consultant and steering committee chair for MyoKardia, Inc, and has served on an advisory board for Ambry Genetics Corp. Dr Olivotto has received grants and honoraria from MyoKardia, Inc, Shire Takeda, and Sanofi Genzyme, honoraria from Menarini International, and grants from Bayer. Cardiopulmonary exercise testing and prognosis in hypertrophic cardiomyopathy. PROs are administered to interrogate quality of life and symptom burden at home and during clinic visits per-protocol (Methods in the Data Supplement). This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Cardiac magnetic resonance (CMR) substudy analysis: Kansas City Cardiomyopathy Questionnaire (KCCQ): Long-term extension study (n = 231, median 62 weeks): Among patients with hypertrophic obstructive cardiomyopathy, mavacamten was superior to placebo. Advances in our understanding of the molecular mechanisms of HCM have led to the development of mavacamtena novel myosin inhibitor that directly targets the underlying pathophysiology of HCM. The US pharma giant is offering to acquire MyoKardia for $225.00 per share in an all-cash deal. About Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy (HCM) is a chronic, progressive disease in which excessive contraction of the heart muscle and reduced ability of the left ventricle to fill can lead to the development of . Effect of Mavacamten on Echocardiographic Features in Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy. Treatment with mavacamten improved exercise capacity, LVOT obstruction, NYHA functional Because echocardiographic data are essential for dose titration and assessment of safety and efficacy, all echocardiographic studies are performed by study-certified sonographers at clinical sites, following a study-specific protocol, and analyzed at the Cardiovascular Imaging Core Laboratory (CICL, Boston, MA). Ann Intern Med. 2020 Jun;13(6):e006853. Obstructive hypertrophic cardiomyopathy (oHCM) is characterized by unexplained left ventricular (LV) hypertrophy associated with dynamic LV outflow tract obstruction. The results unveiled Monday show 37% of patients on mavacamten hit the trial's main goal, compared to 17% . Eligible adults with oHCM and New York Heart Association Functional Class II or III are randomized 1:1 to receive once-daily, oral mavacamten, or matching placebo for 30 weeks. The MAVA-LTE (long-term extension) trial is an ongoing, dose-blinded, 5-year study of mavacamten. Epub 2022 Jun 20. 2021 Oct;17(7):1269-1275. doi: 10.2217/fca-2021-0044. The study includes 12 visits with serial assessment of cardiac structure, function, and symptoms using echocardiography, 12-lead ECG, NYHA functional class, and laboratory testing, including biomarkers (eg, NT-proBNP; Figure [B] and Table III in the Data Supplement). The Mavacamten for Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (Explorer-HCM) trial was a randomized, double-blind, placebo-controlled, phase 3 trial of mavacamten in patients with hypertrophic cardiomyopathy with significant obstruction (LVOT gradient >50 mmHg) and heart failure symptoms (Table 1 ). Study design and rationale of EXPLORER-HCM: evaluation of mavacamten in adults with symptomatic obstructive hypertrophic cardiomyopathy. The power calculation is derived, assuming a clinically meaningful difference of 25% between mavacamten and placebo participants in achieving the primary composite functional end point. Secondary end points include analyses of change from baseline to week 30 for mavacamten versus placebo in the following parameters: postexercise LVOT gradient, pVO2, NYHA class, and 2 PROs: health-related quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire, and HCM core symptoms (shortness of breath subscore) as assessed by a newly developed instrument, the Hypertrophic Cardiomyopathy Symptom Questionnaire (Table and Methods in the Data Supplement). Local Info Bethesda, MD 20894, Web Policies Validation of the Kansas City Cardiomyopathy Questionnaire in Symptomatic Obstructive Hypertrophic Cardiomyopathy. Peak oxygen consumption is an independent predictor of survival and outcomes in obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) patients: results from the international sarcomeric human cardiomyopathies registry (SHaRe). 2022 Aug;10(8):531-539. doi: 10.1016/j.jchf.2022.03.002. "This new analysis of data from the Phase III EXPLORER-HCM trial further supports the scientific evidence suggesting the benefit mavacamten can have on improving health status, symptoms and quality of life in patients with symptomatic oHCM and we look forward to potentially bringing this important new therapy to patients next year." 17-05-2021. Saberi S, Cardim N, Yamani M, et al. Impact of Mavacamten on Artificial Intelligence Electrocardiographic Diagnosis of Hypertrophic Cardiomyopathy in the EXPLORER-HCM Trial Siontis, K Poster - SA2182 Mavacamten treatment for obstructive hypertrophic cardiomyopathy: a clinical trial. Study Design and Rationale of EXPLORER-HCM: Evaluation of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy. Olivotto I, Oreziak A, Barriales-Villa R, et al. The Lancet Regional Health Southeast Asia, The Lancet Regional Health Western Pacific, Italy's first wave of the COVID-19 pandemic has ended: no excess mortality in May, 2020, Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial, Access any 5 articles from the Lancet Family of journals. An official website of the United States government. At ACC 2022, Florian Rader, MD (Cedars-Sinai Medical Center, Los Angeles, CA), shared longer-term data on 231 patients (mean age, 60 years; 39% female) originally enrolled in EXPLORER-HCM and now continuing to be followed in MAVA-LTE. Journal of Managed Care & Specialty Pharmacy, Current Treatment Options in Cardiovascular Medicine, The Journal of Thoracic and Cardiovascular Surgery, Journal of the American College of Cardiology, International Journal of Molecular Sciences, Study Design and Rationale of EXPLORER-HCM, https://www.ahajournals.org/doi/suppl/10.1161/CIRCHEARTFAILURE.120.006853, Considerations for managed care pharmacy in evaluating mavacamten, a novel agent for obstructive hypertrophic cardiomyopathy, Targeted therapies in genetic dilated and hypertrophic cardiomyopathies: from molecular mechanisms to therapeutic targets. Conventionally the medications used for treatment of hypertrophic cardiomyopathy were beta blockers, verapamil and sometimes disopyramide. A small-molecule inhibitor of sarcomere contractility suppresses hypertrophic cardiomyopathy in mice. This medicine improved functional capacity and health status, as assessed by KCCQ. Describe the monitoring protocol for patients on mavacamten. To update your cookie settings, please visit the, Academic & Personal: 24 hour online access, Corporate R&D Professionals: 24 hour online access, https://doi.org/10.1016/S0140-6736(20)31792-X, Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial, Mavacamten: treatment aspirations in hypertrophic cardiomyopathy, Mavacamten for hypertrophic obstructive cardiomyopathy, Mavacamten for hypertrophic obstructive cardiomyopathy Authors' reply, For academic or personal research use, select 'Academic and Personal', For corporate R&D use, select 'Corporate R&D Professionals'. Improvements in symptoms, functional status, and quality of life were clinically significant. QU.AOS.465 - Improving Cardiovascular Health Outcomes Through Real-World Science 10:06 AM - 10:16 AM Effect of Mavacamten on Systolic Anterior Motion of the Mitral Valve and Mitral Regurgitation in Patients with Obstructive Hypertrophic Cardiomyopathy: Insights from the VALOR-HCM Study Ventricular arrhythmia and sudden cardiac death in hypertrophic cardiomyopathy: From bench to bedside. JACC Heart Fail. 2020 Sep 12;396(10253):758. in this phase 3, randomised, double-blind, placebo-controlled trial (explorer-hcm) in 68 clinical cardiovascular centres in 13 countries, patients with hypertrophic cardiomyopathy with an lvot gradient of 50 mm hg or greater and new york heart association (nyha) class ii-iii symptoms were assigned (1:1) to receive mavacamten (starting at 5 mg) or The study was designed to randomize a minimum of 220 participants, with 110 in each of the 2 treatment groups. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Once all participants have completed their week 38/end-of-study visit, all data will be cleaned and locked. Current medical therapies are nonspecific and have limited efficacy in relieving symptoms.
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