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New heart drug aficamten challenges standard Beta-Blocker in major trial

NCT ID NCT05767346

Disease control Sponsor: Cytokinetics Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called aficamten against the standard medicine metoprolol in 175 adults with a heart condition that makes the heart muscle thick and blocks blood flow. The goal was to see which drug better improves exercise ability and symptoms like shortness of breath. Participants took either aficamten or metoprolol for 24 weeks, and their exercise capacity was measured with a special test.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

175 people

The number who actually took part.

Started

Jun 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hypertrophic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive hypertrophic cardiomyopathy (OHCM)

Contacts and locations

Locations

  • AOU Careggi

    Florence, Italy

  • Aarhus University Hospital

    Aarhus, Denmark

  • AdventHealth

    Orlando, Florida, 32804, United States

  • Alaska Heart and Vascular Institute

    Anchorage, Alaska, 99508, United States

  • Ascension Saint Thomas Heart West

    Nashville, Tennessee, 37205, United States

  • Barts Health NHS Trust

    London, United Kingdom

  • Barzilai Medical Center

    Ashkelon, Israel

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHI St. Luke's Health Baylor-St. Luke's Medical Center

    Houston, Texas, 77030, United States

  • CHU La Timone

    Marseille, France

  • CHU Pontchaillou

    Rennes, France

  • Cedars-Sinai Medical Center (Smidt Heart Institute)

    Los Angeles, California, 90048, United States

  • Charite-Universitatsmedizin Berlin - Campus Virchow Klinikum

    Berlin, Germany

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, Spain

  • Copenhagen University Hospital

    Copenhagen, Denmark

  • Division of Heart Failure and Transplantation (Hospital of the University of Pennsylvania)

    Philadelphia, Pennsylvania, 19104, United States

  • Duke Health Center Arringdon

    Morrisville, North Carolina, 27560, United States

  • Emory Clinic

    Atlanta, Georgia, 30322, United States

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Guangdong Provincial People's Hospital

    Guangzhou, China

  • Hadassah Hebrew Medical Center- Ein Kerem

    Jerusalem, Israel

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hopital Cardiologique Haut Leveque - CHU de Bordeaux

    Pessac, France

  • Hopital Europeen Georges Pompidou

    Paris, France

  • Hopital Laennec - CHU de Nantes

    Saint-Herblain, France

  • Hopital Lariboisiere - APHP

    Paris, France

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital Clinico Universitario Virgen Arrixaca

    El Palmar, Spain

  • Hospital Universitario Puerta de Hierro

    Madrid, Spain

  • Hospital Universitario Son Llatzer

    Son Ferriol, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital Universitario de Salamanca

    Salamanca, Spain

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Inova Schar Heart and Vascular

    Falls Church, Virginia, 22042, United States

  • Institut universitaire de cardiologie et de pneumonlogie de Quebec - Universite Laval

    Québec, Canada

  • Institutdo Danta Pazzanese

    Ibirapuera, 04012-909, Brazil

  • Instituto de Pesquisa Clinica de Campinas - IPECC

    Campinas, São Paulo, 13060-080, Brazil

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Kaplan Medical Center

    Rehovot, Israel

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01803, United States

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, United Kingdom

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • NHS Greater Glasgow and Clyde

    Glasgow, United Kingdom

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Oxford University Hospital NHS Trust - John Radcliffe Hospital - OCMR

    Oxford, United Kingdom

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214, United States

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225, United States

  • Renmin Hospital of Wuhan University

    Wuhan, China

  • Royal Brompton Hospital

    London, United Kingdom

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Sanger Heart & Vascular Institute - HCM Clinic

    Charlotte, North Carolina, 28204, United States

  • Semmelweis Egyetem, Városmajori Szív- és Érgyógyászati Klinika

    Budapest, Hungary

  • St George's University Hospitals NHS Foundation Trust

    London, United Kingdom

  • The Chaim Sheba Medical Center

    Ramat Gan, Israel

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080, China

  • UC San Diego Health - Sulpizio Cardiovascular Center

    La Jolla, California, 92037, United States

  • Universitaetsklinikum Essen

    Essen, Germany

  • Universitaetsklinikum Jena

    Jena, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Xiangya Second Hospital of Central South University

    Changsha, China

  • Yale New Haven Hospital

    New Haven, Connecticut, 06519, United States

  • Zhongshan Hospital Fudan University

    Shanghai, China

  • Ziv Medical Center

    Safed, Israel

  • lnstituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, São Paulo, 05403-900, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.