Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM (FOREST-HCM)

February 23, 2024 updated by: Cytokinetics

A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment of Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha, Czechia, 128 08
        • Il. Interni klinika kardiologie a angiologie
  • Denmark
      • Aarhus, Denmark, 8200
        • Department of Cardiology Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • The Heart Center, Department of Cardiology
      • Copenhagen, Denmark, 2400
        • Copenhagen University Hospital
  • France
      • Marseille, France, 130005
        • Hopital de la Timone Service de cardiologie
      • Nantes, France, 44093
        • CHU de Nantes Institut Du Thorax et du systeme nerveux Clinique Cardiologique et des Maladies Vasculaires
      • Paris, France, 75015
        • Hôpital européen Georges Pompidou
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Pessac, France, 33604
        • Hopital cardiologique de Haut-Leveque
  • Germany
      • Goettigen, Germany, 37075
        • Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie
      • Würzburg, Germany, 97078
        • Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC)
  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
  • Israel
      • Ashkelon, Israel, 7830604
        • The Barzilai University Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center- Ein Kerem
      • Ramat Gan, Israel, 5265601
        • The Chaim Sheba Medical Center
      • Safed, Israel, 1311001
        • Ziv Medical Center
  • Italy
      • Firenze, Italy, 50134
        • Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
      • Pisa, Italy, 56124
        • Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo
      • Roma, Italy, 00189
        • Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center (MUMC)
      • Rotterdam, Netherlands, 3015
        • Erasmus Medical Center Department of Cardiology
  • Poland
      • Katowice, Poland, 40-555
        • Kardio Brynow S.C.
      • Warszawa, Poland, 04-628
        • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca
  • Portugal
      • Aveiro, Portugal, 3814-501
        • Centro Hospitalar Do Baixo Vouga, EPE Cardiology Department
  • Spain
      • Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Madrid, Spain, 28220
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Madrid, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena-merge
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust
      • Glasgow, United Kingdom, G51 4TF
        • Glasgow Clinical Research Facility Neuroscience Institute
      • Liverpool, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust
      • Oxford, United Kingdom, OX3 9DU
        • Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Heart and Vascular Institute
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego Health - Sulpizio Cardiovascular Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center (Smidt Heart Institute)
      • Los Angeles, California, United States, 90048
        • Cedar-Sinai Medical Center
      • San Francisco, California, United States, 94143
        • UCSF Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital / Cardiology Associates
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Medicine - University of Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke'S Hospital of Kansas City
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10032
        • Columbia University Medical Center/New York Presbyterian Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Sanger Heart & Vascular Institute - HCM Clinic
      • Durham, North Carolina, United States, 27710
        • Duke Cardiology at Southpoint
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 76104
        • Ascension St. John Clinical Research Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Completion of a Cytokinetics trial investigating CK-3773274
  • LVEF ≥55% at the Screening Visit

Exclusion Criteria:

  • Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
  • Has participated in another investigational device or drug study or received an investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.

  • Since completion of a previous trial of CK-3773274 has:

    • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days
    • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the completion of a prior trial of CK-3773274.
  • Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with CK-3773274
  • History of appropriate ICD shock within 30 days prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CK-3773274 up to 20 mg
Patients in this arm take daily dose of CK-3773274. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.
Drug: CK-3773274 (5 - 20 mg)
CK-3773274 tablets administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events observed during dosing of CK-3773274 in patients with HCM
Time Frame: Baseline to End of study, up to 5 years
Patient incidence of reported Adverse Events (AEs)
Baseline to End of study, up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious adverse events observed during dosing of CK-3773274 in patients with HCM
Time Frame: Baseline to End of study, up to 5 years
Patient incidence of reported Serious Adverse Events (SAEs)
Baseline to End of study, up to 5 years
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with HCM
Time Frame: Baseline to End of study, up to 5 years
Patient incidence of reported LVEF <50%
Baseline to End of study, up to 5 years
Long-term effects of CK-3773274 on left ventricular outflow tract gradient (LVOT G) in patients with oHCM
Time Frame: Baseline through the end of participation at 12-week intervals
Peak LVOT-G at rest
Baseline through the end of participation at 12-week intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytokinetics

Investigators

  • Study Director: Cytokinetics, MD, Cytokinetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CY 6022
  • 2020-003571-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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