Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT05767346

PHASE3

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

Sponsor: Cytokinetics

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

Official title: A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

175

Start Date

2023-06-20

Completion Date

2025-03-28

Last Updated

2026-06-09

Healthy Volunteers

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Interventions

DRUG

Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg)

Aficamten (CK-3773274) tablets administered orally

DRUG

Placebo to match aficamten

Placebo for aficamten (CK-3773274) administered orally

DRUG

Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)

Metoprolol succinate tablets administered orally

DRUG

Placebo to match metoprolol succinate

Placebo for metoprolol succinate administered orally

Inclusion Criteria: * Participants who meet all the following criteria at screening may be included in the trial: * 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 * New York Heart Association (NYHA) class II or III * Has a Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) score of ≤ 90 at screening * Has a screening echocardiogram with the following determined by the echocardiography core laboratory: * Resting left ventricular outflow tract gradient (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 cardiopulmonary exercise testing (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: * Any of the following criteria will exclude potential participants from the trial: * 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 Systolic Blood Pressure (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

Locations (71)

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

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

Institutdo Danta Pazzanese

Ibirapuera, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)