Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
NCT ID: NCT05767346
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
175 participants
INTERVENTIONAL
2023-06-20
2025-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Aficamten up to 20 mg plus placebo for metoprolol
Patients will receive doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten (CK-3773274) plus placebo for metoprolol succinate with dose levels guided by echocardiography assessments for up to 24 weeks.
Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg)
Aficamten (CK-3773274) tablets administered orally
Placebo to match metoprolol succinate
Placebo for metoprolol succinate administered orally
Metoprolol succinate up to 200 mg plus placebo for aficamten
Patients will receive 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten (CK-3773274) with dose levels guided by echocardiography and heart rate assessments for up to 24 weeks.
Placebo to match aficamten
Placebo for aficamten (CK-3773274) administered orally
Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
Metoprolol succinate tablets administered orally
Interventions
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Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg)
Aficamten (CK-3773274) tablets administered orally
Placebo to match aficamten
Placebo for aficamten (CK-3773274) administered orally
Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
Metoprolol succinate tablets administered orally
Placebo to match metoprolol succinate
Placebo for metoprolol succinate administered orally
Eligibility Criteria
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Inclusion Criteria
* Males and females between 18 to 85 years of age, inclusive, at screening
* Body mass index \< 35 kg/m2
* Diagnosed with oHCM per the following criteria by cardiac magnetic resonance imaging (CMR) or echocardiography -
* Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease and
* Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory:
1. ≥ 15 mm in one or more myocardial segments OR
2. ≥ 13 mm in one or more wall segments and a known disease-causing gene mutation or positive family history of HCM
* NYHA class II or III
* Has a KCCQ-CSS score of ≤ 90 at screening
* Has a screening echocardiogram with the following determined by the echocardiography core laboratory:
* Resting LVOT-G \> 30 mm Hg and/or post-Valsalva LVOT-G ≥ 50 mmHg at screening AND
* LVEF ≥ 60%
* Hemoglobin ≥ 10g/dL
* Respiratory exchange ratio (RER) ≥ 1.05 and peak oxygen uptake (pVO2) \< 100% predicted on the screening CPET per the core laboratory
* Patients previously exposed to mavacamten are allowed to participate but must be off mavacamten for at least 8 weeks
Exclusion Criteria
* Medical indication for either beta blocker or calcium-channel blockers prohibiting drug discontinuation other than oHCM
* History of intolerance or medical contraindication to beta blocker therapy
* Resting SBP of \> 160 mmHg
* Resting heart rate of \> 100 bpm
* Significant valvular heart disease
1. Moderate-severe valvular aortic stenosis or fixed subaortic obstruction
2. Mitral regurgitation not due to systolic anterior motion of the mitral valve (per Investigator judgment)
* Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
* History of LV systolic dysfunction (LVEF \< 45%) or stress cardiomyopathy at any time during their clinical course
* Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
* Documented room air oxygen saturation reading \< 90% at screening
* Planned septal reduction treatment that cannot be deferred during the trial period
* History of septal reduction therapy (surgical myectomy or alcohol septal ablation) within 6 months of screening
* History of paroxysmal or persistent atrial fibrillation or atrial flutter. Atrial flutter treated with radio frequency ablation without recurrence within the last 6 months prior to screening is allowed.
* Current or recent (\< 4 weeks) therapy with disopyramide
* History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
* Has received prior treatment with aficamten or previously intolerant (reduced LVEF requiring permanent drug discontinuation) to mavacamten
18 Years
85 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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Scientific Leadership
Role: STUDY_DIRECTOR
Cytokinetics
Locations
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Alaska Heart and Vascular Institute
Anchorage, Alaska, United States
Mayo Clinic
Phoenix, Arizona, United States
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
AdventHealth
Orlando, Florida, United States
Emory Clinic
Atlanta, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Northwestern University
Evanston, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Sanger Heart & Vascular Institute - HCM Clinic
Charlotte, North Carolina, United States
Duke Health Center Arringdon
Morrisville, North Carolina, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Division of Heart Failure and Transplantation (Hospital of the University of Pennsylvania)
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Ascension Saint Thomas Heart West
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
CHI St. Luke's Health Baylor-St. Luke's Medical Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Inova Schar Heart and Vascular
Falls Church, Virginia, United States
Institutdo Danta Pazzanese
Ibirapuera, Ibirapuera, Brazil
Instituto de Pesquisa Clinica de Campinas - IPECC
Campinas, São Paulo, Brazil
lnstituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
Institut universitaire de cardiologie et de pneumonlogie de Quebec - Universite Laval
Québec, , Canada
Xiangya Second Hospital of Central South University
Changsha, , China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Renmin Hospital of Wuhan University
Wuhan, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Aarhus University Hospital
Aarhus, , Denmark
Copenhagen University Hospital
Copenhagen, , Denmark
CHU La Timone
Marseille, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Lariboisiere - APHP
Paris, , France
Hopital Cardiologique Haut Leveque - CHU de Bordeaux
Pessac, , France
CHU Pontchaillou
Rennes, , France
Hopital Laennec - CHU de Nantes
Saint-Herblain, , France
Charite-Universitatsmedizin Berlin - Campus Virchow Klinikum
Berlin, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Semmelweis Egyetem, Városmajori Szív- és Érgyógyászati Klinika
Budapest, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Hadassah Hebrew Medical Center- Ein Kerem
Jerusalem, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Ziv Medical Center
Safed, , Israel
AOU Careggi
Florence, , Italy
Erasmus Medical Center
Rotterdam, , Netherlands
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Clinico Universitario Virgen Arrixaca
El Palmar, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Son Llatzer
Son Ferriol, , Spain
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Oxford University Hospital NHS Trust - John Radcliffe Hospital - OCMR
Oxford, , United Kingdom
Countries
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References
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Hegde SM, Wang X, Garcia-Pavia P, Getchevski S, Masri A, Merkely B, Nassif ME, Pena-Pena ML, Barriales-Villa R, Bilen O, Burroughs M, Claggett B, Costabel JP, Correia EB, Dybro AM, Elliott P, Lakdawala NK, Mann A, Maron MS, Nair A, Poulsen SH, Reant P, Schulze PC, Wang A, Sohn R, Berhane I, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Wohltman A, Fifer MA, Solomon SD; MAPLE-HCM Investigators. Effect of Aficamten Compared With Metoprolol on Echocardiographic Measures in Symptomatic Obstructive Hypertrophic Cardiomyopathy: MAPLE-HCM. J Am Coll Cardiol. 2025 Aug 27:S0735-1097(25)07466-2. doi: 10.1016/j.jacc.2025.08.022. Online ahead of print.
Garcia-Pavia P, Maron MS, Masri A, Merkely B, Nassif ME, Pena-Pena ML, Barriales-Villa R, Bilen O, Burroughs M, Claggett B, Costabel JP, Correia EB, Dybro AM, Elliott P, Hegde SM, Lakdawala NK, Lewis GD, Mann A, Miao ZM, Nair A, Poulsen SH, Reant P, Schulze PC, Solomon SD, Wang A, Sohn R, Berhane I, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Wohltman A, Fifer MA; MAPLE-HCM Investigators. Aficamten or Metoprolol Monotherapy for Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. 2025 Sep 11;393(10):949-960. doi: 10.1056/NEJMoa2504654. Epub 2025 Aug 30.
Garcia-Pavia P, Bilen O, Burroughs M, Costabel JP, de Barros Correia E, Dybro AM, Elliott P, Lakdawala NK, Mann A, Nair A, Nassif ME, Poulsen SH, Reant P, Schulze PC, Wang A, Berhane I, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Meng L, Sohn R, Wohltman A, Fifer MA; MAPLE-HCM Study Investigators. Aficamten vs Metoprolol for Obstructive Hypertrophic Cardiomyopathy: MAPLE-HCM Rationale, Study Design, and Baseline Characteristics. JACC Heart Fail. 2025 Feb;13(2):346-357. doi: 10.1016/j.jchf.2024.11.011.
Other Identifiers
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2023-504809-37-00
Identifier Type: OTHER
Identifier Source: secondary_id
CY 6032
Identifier Type: -
Identifier Source: org_study_id
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