Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM

NCT05186818 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CY 60312021-003536-92
• Study Type: interventional
• Target: 282
• Locations: 14 countries
• Sites: 114

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) versus placebo in adults with symptomatic hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction.

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords

Obstructive Hypertrophic Cardiomyopathy; oHCM; CK-3773274; CK-274; Aficamten; SEQUOIA-HCM; CY 6031; SEQUOIA

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in pVO2 at Week 24

  The effect of CK-3773274 on exercise capacity in participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) was determined through changes in peak oxygen uptake (pVO2) after 24 weeks of treatment. pVO2 was measured by cardiopulmonary exercise testing (CPET) on a treadmill or bicycle. A higher pVO2 indicates better cardiorespiratory fitness.

  Baseline to Week 24

Secondary Outcomes (10)

• Change From Baseline in KCCQ-CSS at Week 24

  Baseline to Week 24

• Change From Baseline in KCCQ-CSS at Week 12

  Baseline to Week 12

• Proportion of Participants With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class From Baseline to Week 24

  Baseline to Week 24

• Proportion of Participants With ≥1 Class Improvement in NYHA Functional Class From Baseline to Week 12

  Baseline to Week 12

• Change From Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G) at Week 24

  Baseline to Week 24

Study Arms (2)

Aficamten up to 20 mg

EXPERIMENTAL

Participants received 5 mg, 10 mg, 15 mg, or 20 mg of aficamten; dose levels were guided by echocardiography assessments. Treatment was administered for up to 24 weeks.

Drug: Aficamten (5 mg, 10 mg, 15 mg, and 20 mg)

Placebo to match aficamten

PLACEBO COMPARATOR

Participants received placebo for up to 24 weeks.

Drug: Placebo to match aficamten

Interventions

Aficamten (5 mg, 10 mg, 15 mg, and 20 mg) DRUG

Aficamten tablets were administered orally once daily.

Also known as: CK-3773274

Aficamten up to 20 mg

Placebo to match aficamten DRUG

Placebo tablets were administered orally once daily.

Also known as: Placebo

Placebo to match aficamten

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18 and 85 years of age, inclusive, at screening.
• Body mass index \<35 kg/m2.
• Diagnosed with HCM per the following criteria:
• Has LV hypertrophy and 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 of:
• ≥15 mm in one or more myocardial segments OR
• ≥13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM
• Has resting LVOT-G ≥30 mmHg and post-Valsalva LVOT G ≥50 mmHg during screening as determined by the echocardiography core laboratory.
• LVEF ≥60% at screening as determined by the echocardiography core laboratory.
• New York Heart Association (NYHA) Functional Class II or III at screening.
• Hemoglobin ≥10g/dL at screening.
• Respiratory exchange ratio (RER) ≥1.05 and pVO2 ≤90% predicted on the screening CPET per the core laboratory.
• Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for \>6 weeks prior to randomization and anticipate remaining on the same medication regimen during the trial. Patients treated with disopyramide must also be concomitantly treated with a beta blocker and/or calcium channel blocker.

You may not qualify if:

• Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
• Significant valvular heart disease (per investigator judgment).
• Moderate-severe valvular aortic stenosis.
• Moderate-severe mitral regurgitation not due to systolic anterior motion of the mitral valve.
• 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).
• Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the trial period.
• Documented paroxysmal atrial fibrillation during the screening period.
• Paroxysmal or permanent atrial fibrillation is only excluded IF:
• rhythm restoring treatment (eg, direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤6 months prior to screening.
• rate control and anticoagulation have not been achieved for at least 6 months prior to screening.
• History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
• Has received prior treatment with CK-3773274 or mavacamten.

Sponsors & Collaborators

• Cytokinetics: lead
• Corxel Pharmaceuticals: collaborator

Study Sites (114)

Alaska Heart and Vascular Institute

Anchorage, Alaska, 99508, United States

Location

UC San Diego Health - Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center - Smidt Heart Institute Clinic

Los Angeles, California, 90048, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University Hospital

Stanford, California, 94305, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Holy Cross Hospital / Cardiology Associates

Fort Lauderdale, Florida, 33308, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States

Location

Northwestern University

Chicago, Illinois, 60614, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MedStar Medical Group Cardiology at Union Memorial

Baltimore, Maryland, 21218, United States

Location

Medstar Franklin Square Medical Center

Baltimore, Maryland, 21237, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Spectrum Health Medical Group Cardiovascular Medicine

Grand Rapids, Michigan, 49525, United States

Location

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Medical Center/NY Presbyterian Hospital

New York, New York, 10032, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 10595, United States

Location

Sanger Heart and Vascular Institute - HCM Clinic

Charlotte, North Carolina, 28204, United States

Location

Duke Health Center Arringdon

Morrisville, North Carolina, 27560, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Ascension St. John Clinical Research Institute

Tulsa, Oklahoma, 74104, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Stern Cardiovascular Foundation, Inc

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

University of Virginia Health System University Hospital

Charlottesville, Virginia, 22908, United States

Location

University of Washington Medical

Seattle, Washington, 98195, United States

Location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 10019, China

Location

Nanfang Hospital Southern Medical University

Guanzhou, Guangdong, 516006, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450018, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Xiangya Hospital of the Central South University

Changsha, Hunan, 410008, China

Location

The First Hospital of Jinlin University

Changchun, Jinlin, 130031, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Charles University

Prague, 128 08, Czechia

Location

Interni klinika kardiologie a angiologie

Prague, 12808, Czechia

Location

Aalborg University Hospital, Department of Cardiology

Aalborg, 9100, Denmark

Location

Department of Cardiology Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Hjertecentret (The Heart Center)

Copenhagen, 2100, Denmark

Location

Copenhagen University Hospital

Copenhagen, 2400, Denmark

Location

Hopital Universitaire de Rangueil (CHU de Toulouse) Service de Cardiologie

Toulouse, Cedex, 31059, France

Location

CHU de Marseille - Hopital de la Timone Service de cardiologie

Marseille, 13005, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hopital Lariboisiere, Service de Cardiologie

Paris, 75010, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

CHU Pitie-Salpetriere, Centre de reference maladies cardiaques hereditaires ou rares

Paris, France

Location

CHU de Bordeaux Hopital Cardiologique Haut-Leveque

Pessac, 33600, France

Location

CHU du Haut Lveque Cardiologie

Pessac, 33604, France

Location

Kerckhoff-Klinik GmbH Abteilung Administration Forschung und Lehre

Bad Nauheim, 61231, Germany

Location

Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie

Berlin, 13353, Germany

Location

Universitaetsklinikum Essen Westdeutsches Herz-Gefaesszentrum

Essen, 45147, Germany

Location

Klinikumder Georg-August-Universitaet

Göttingen, 37075, Germany

Location

Universitaetsmedizin Goettingen

Göttingen, 37075, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Location

Universitaetsklinikum Jena Klinik fuer Innere Medizin 1

Jena, 07747, Germany

Location

Unniversitaetsklinikum Magdeburg Klinik fur Kardiologie und Anglologie

Magdeburg, 39120, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

Semmelweis Egyetem Varosmajori Sziv es Ergyogyasazati Klinika

Budapest, Hungary

Location

The Olga & Lev Leviev Heart Center The Chaim Sheba Medical Center

Ramat Gan, Tel Hasomer, 5265601, Israel

Location

The Barzilai University Medical Center

Ashkelon, 78100, Israel

Location

The Barzilai University Medical Center

Ashkelon, 7830604, Israel

Location

Hadassah Medical Center- Ein Kerem

Jerusalem, 9112001, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Ziv Medical Center

Safed, 13100, Israel

Location

UOC Cardiologica Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Azienda Ospedaliero Universitaria Careggi Dipartimento Cardiotoracovascolare - Cardiomiopatie Unit

Florence, 50134, Italy

Location

Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo

Pisa, 56124, Italy

Location

Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea

Roma, 1035-39, Italy

Location

Amsterdam UMC, location AMC

Amsterdam, 1105, Netherlands

Location

University Hospital Maastricht

Maastricht, 6229HX, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015, Netherlands

Location

Narodowy Instytut Kardiologii Stefana Kardynała Wyszynskiego- Panstwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, 04-628, Poland

Location

Kardio Brynow S.C

Katowice, Poland

Location

Krakowskie Centrum

Krakow, Poland

Location

Centro Hospitalar Do Baixo Vouga, EPE AV ARTUR RAVARA

Aveiro, 3814-501, Portugal

Location

Hospital da Luz

Lisbon, 1500-650, Portugal

Location

Complejo Hospitalario Universitario

A Coruña, La Coruna, 15006, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Majadahonda, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario Son Llatzer Secretaria de Cardiologia

Palma, 07198, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen Macarena-merge

Seville, 41009, Spain

Location

Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust

Edgbaston, Birmingham, B15 2GW, United Kingdom

Location

Queen Elizabeth University Hospital - HWS Greater Glasgow and Clyde

Glasgow, G1 4TF, United Kingdom

Location

Liverpool Heart and Chest Hospital - Liverpool Heart and Chest Hospital NHS Foundation Trust- HWS Greater Glasgow and Clyde

Liverpool, L14 3LB, United Kingdom

Location

Barts Health NS Trust

London, EC1A 7BE, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Oxford Centre for Clinical Magnetic Resonance Research

Oxford, OX3 9DU, United Kingdom

Location

Radcliffe Department of Medicine

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (10)

• Kaski JP, Kantor PF, Nakano SJ, Olivotto I, Russell MW, Godown J, Chiu M, German P, Heitner SB, Jacoby DL, Kupfer S, Lutz J, Maharao N, Malik FI, Melloni C, Nieto Morales PF, Simkins T, Wei J, Ho CY; CEDAR-HCM Investigators. Efficacy and Safety of Aficamten in Children and Adolescents With Obstructive Hypertrophic Cardiomyopathy: Study Design and Rationale of CEDAR-HCM. Circ Heart Fail. 2026 Feb;19(2):e013418. doi: 10.1161/CIRCHEARTFAILURE.125.013418. Epub 2025 Dec 5.

  PMID: 41347307 DERIVED

• Campain J, Griskowitz C, Newlands C, Claggett BL, Kulac IJ, McGinnis S, Giverts I, Moreno F, Minasian A, Prasad C, Rupert L, Landsteiner I, Iskenderian N, Coats CJ, Lee MMY, Maron MS, Owens AT, Jacoby DL, Heitner SB, Kupfer S, Malik FI, Wohltman A, Malhotra R, Lewis GD. Characterization and Application of Novel Exercise Recovery Patterns That Reflect Cardiac Performance: A Substudy of the SEQUOIA-HCM Trial. Circulation. 2025 Oct 7;152(14):990-1002. doi: 10.1161/CIRCULATIONAHA.124.073585. Epub 2025 Sep 5.

  PMID: 40910168 DERIVED

• Maron MS, Masri A, Nassif ME, Barriales-Villa R, Abraham TP, Arad M, Cardim N, Choudhury L, Claggett B, Coats CJ, Dungen HD, Garcia-Pavia P, Hagege AA, Januzzi JL, Kulac I, Lee MMY, Lewis GD, Ma CS, Michels M, Oreziak A, Owens AT, Spertus JA, Solomon SD, Tfelt-Hansen J, van Sinttruije M, Veselka J, Watkins HC, Jacoby DL, Heitner SB, Kupfer S, Malik FI, Meng L, Wohltman A, Olivotto I; SEQUOIA-HCM Investigators. Impact of Aficamten on Disease and Symptom Burden in Obstructive Hypertrophic Cardiomyopathy: Results From SEQUOIA-HCM. J Am Coll Cardiol. 2024 Nov 5;84(19):1821-1831. doi: 10.1016/j.jacc.2024.09.003. Epub 2024 Sep 30.

  PMID: 39352339 DERIVED

• Lee MMY, Masri A, Nassif ME, Barriales-Villa R, Abraham TP, Claggett BL, Coats CJ, Gimeno JR, Kulac IJ, Landsteiner I, Ma C, Maron MS, Olivotto I, Owens AT, Solomon SD, Veselka J, Jacoby DL, Heitner SB, Kupfer S, Malik FI, Meng L, Wohltman A, Lewis GD; SEQUOIA-HCM Investigators. Aficamten and Cardiopulmonary Exercise Test Performance: A Substudy of the SEQUOIA-HCM Randomized Clinical Trial. JAMA Cardiol. 2024 Nov 1;9(11):990-1000. doi: 10.1001/jamacardio.2024.2781.

  PMID: 39230885 DERIVED

• Sherrod CF 4th, Saberi S, Nassif ME, Claggett BL, Coats CJ, Garcia-Pavia P, Januzzi JL, Lewis GD, Ma C, Maron MS, Miao ZM, Olivotto I, Veselka J, Butzner M, Jacoby DL, Heitner SB, Kupfer S, Malik FI, Meng L, Wohltman A, Spertus JA. Effect of Aficamten on Health Status Outcomes in Obstructive Hypertrophic Cardiomyopathy: Results From SEQUOIA-HCM. J Am Coll Cardiol. 2024 Nov 5;84(19):1773-1785. doi: 10.1016/j.jacc.2024.08.014. Epub 2024 Sep 1.

  PMID: 39217569 DERIVED

• Masri A, Cardoso RN, Abraham TP, Claggett BL, Coats CJ, Hegde SM, Kulac IJ, Lee MMY, Maron MS, Merkely B, Michels M, Olivotto I, Oreziak A, Jacoby DL, Heitner SB, Kupfer S, Malik FI, Meng L, Solomon SD, Wohltman A, Kwong RY, Kramer CM; SEQUOIA-HCM Investigators. Effect of Aficamten on Cardiac Structure and Function in Obstructive Hypertrophic Cardiomyopathy: SEQUOIA-HCM CMR Substudy. J Am Coll Cardiol. 2024 Nov 5;84(19):1806-1817. doi: 10.1016/j.jacc.2024.08.015. Epub 2024 Sep 1.

  PMID: 39217563 DERIVED

• Hegde SM, Claggett BL, Wang X, Jering K, Prasad N, Roshanali F, Masri A, Nassif ME, Barriales-Villa R, Abraham TP, Cardim N, Coats CJ, Kramer CM, Maron MS, Michels M, Olivotto I, Saberi S, Jacoby DL, Heitner SB, Kupfer S, Meng L, Wohltman A, Malik FI, Solomon SD; SEQUOIA-HCM Investigators. Impact of Aficamten on Echocardiographic Cardiac Structure and Function in Symptomatic Obstructive Hypertrophic Cardiomyopathy. J Am Coll Cardiol. 2024 Nov 5;84(19):1789-1802. doi: 10.1016/j.jacc.2024.08.002. Epub 2024 Sep 1.

  PMID: 39217556 DERIVED

• Coats CJ, Masri A, Nassif ME, Barriales-Villa R, Arad M, Cardim N, Choudhury L, Claggett B, Dungen HD, Garcia-Pavia P, Hagege AA, Januzzi JL, Lee MMY, Lewis GD, Ma CS, Maron MS, Miao ZM, Michels M, Olivotto I, Oreziak A, Owens AT, Spertus JA, Solomon SD, Tfelt-Hansen J, van Sinttruije M, Veselka J, Watkins H, Jacoby DL, German P, Heitner SB, Kupfer S, Lutz JD, Malik FI, Meng L, Wohltman A, Abraham TP; SEQUOIA-HCM Investigators *. Dosing and Safety Profile of Aficamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy: Results From SEQUOIA-HCM. J Am Heart Assoc. 2024 Aug 6;13(15):e035993. doi: 10.1161/JAHA.124.035993. Epub 2024 Jul 26.

  PMID: 39056349 DERIVED

• Maron MS, Masri A, Nassif ME, Barriales-Villa R, Arad M, Cardim N, Choudhury L, Claggett B, Coats CJ, Dungen HD, Garcia-Pavia P, Hagege AA, Januzzi JL, Lee MMY, Lewis GD, Ma CS, Michels M, Olivotto I, Oreziak A, Owens AT, Spertus JA, Solomon SD, Tfelt-Hansen J, van Sinttruije M, Veselka J, Watkins H, Jacoby DL, Heitner SB, Kupfer S, Malik FI, Meng L, Wohltman A, Abraham TP; SEQUOIA-HCM Investigators. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. 2024 May 30;390(20):1849-1861. doi: 10.1056/NEJMoa2401424. Epub 2024 May 13.

  PMID: 38739079 DERIVED

• Coats CJ, Maron MS, Abraham TP, Olivotto I, Lee MMY, Arad M, Cardim N, Ma CS, Choudhury L, Dungen HD, Garcia-Pavia P, Hagege AA, Lewis GD, Michels M, Oreziak A, Owens AT, Tfelt-Hansen J, Veselka J, Watkins HC, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Meng L, Wohltman A, Masri A; SEQUOIA-HCM Investigators. Exercise Capacity in Patients With Obstructive Hypertrophic Cardiomyopathy: SEQUOIA-HCM Baseline Characteristics and Study Design. JACC Heart Fail. 2024 Jan;12(1):199-215. doi: 10.1016/j.jchf.2023.10.004. Epub 2023 Nov 29.

  PMID: 38032573 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Results Point of Contact

• Title: MD Cytokinetics
• Organization: Cytokinetics, Inc.

medicalaffairs@cytokinetics.com

650-624-2929

Study Officials

• Cytokinetics MD

  Cytokinetics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: February 1, 2022
• Primary Completion: November 10, 2023
• Study Completion: December 18, 2023
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2025-02

Locations

FR (8); PT (2); ES (7); CN (9); PL (3); US (48); IL (6); GB (8); CZ (2); DK (4); IT (4); NL (3); HU (1); DE (9)