Clinical trial NCT04848506: Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Official title: A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Symptomatic Hypertrophic Cardiomyopathy (HCM)
Keywords: Obstructive Hypertrophic Cardiomyopathy
oHCM
CK-3773274
CK-274
Non obstructive hypertrophic cardiomyopathy
nHCM
HCM
Hypertrophic cardiomyopathy
Aficamten
REDWOOD-OLE
CY 6022
FOREST-HCM
Forest
Lead sponsor: Cytokinetics
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect long-term safety and tolerability data for aficamten.


Eligibility criteria: Inclusion Criteria:

* Completion of a Cytokinetics trial investigating aficamten
* 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 aficamten 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)
* Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten
* History of implantable ICD placement within 30 days prior to screening.

Primary outcomes:
measure: Incidence of adverse events observed during dosing of aficamten in patients with HCM
timeFrame: Baseline to End of study, up to 5 years
Secondary outcomes:
measure: Incidence of serious adverse events observed during dosing of aficamten in patients with HCM
timeFrame: Baseline to End of study, up to 5 years
measure: Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM
timeFrame: Baseline to End of study, up to 5 years
measure: Long-term effects of aficamten on left ventricular outflow tract gradient (LVOT G) in patients with oHCM
timeFrame: Baseline through the end of participation at 12-24 week intervals
measure: Long-term effects of aficamten on resting LVOT-G
timeFrame: Baseline through the end of participation at 12-24 week intervals
measure: Long-term effects of aficamten on post Valsalva LVOT-G
timeFrame: Baseline through the end of participation at 12-24 week intervals
measure: Long-term effects of aficamten on post Valsalva LVOT-G
timeFrame: Baseline through the end of participation at 12-24 week intervals
measure: Long-term effects of aficamten on left ventricular ejection fraction (LVEF) and post-Valsalva LVOT-G
timeFrame: Baseline through the end of participation at 12-24 week intervals
measure: Long-term effects of aficamten on time to first resting LVOT-G < 30 mmHg through last follow-up
timeFrame: Time to the following event through last follow-up, up to 5 years
measure: Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 50 mmHg through last follow-up
timeFrame: Time to the following event through last follow-up, up to 5 years
measure: Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 30 mmHg through last follow-up
timeFrame: Time to the following event through last follow-up, up to 5 years
measure: Long-term effects of aficamten on time to first LVEF ≥ 50%, resting LVOT-G < 30 mmHg, and post-Valsalva LVOT-G < 50 mmHg through last follow-up
timeFrame: Time to the following event through last follow-up, up to 5 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Heart and Vascular Institute
state: Alaska
city: Phoenix
country: United States
facility: Mayo Clinic Building - Phoenix
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego Health - Sulpizio Cardiovascular Center
state: California
city: Los Angeles
country: United States
facility: Cedar-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center (Smidt Heart Institute)
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital / Cardiology Associates
state: Florida
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Fayetteville
country: United States
facility: Piedmont Fayette Hospital
state: Georgia
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine - University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Charlotte
country: United States
facility: Sanger Heart & Vascular Institute - HCM Clinic
state: North Carolina
city: Durham
country: United States
facility: Duke Cardiology at Southpoint
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Ascension St. John Clinical Research Institute
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
state: Pennsylvania
city: Pittsburg
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Ascension Saint Thomas Heart West
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System University Hospital
state: Virginia
city: Falls Church
country: United States
facility: Inova Health Care Services
state: Virginia
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Quebec-Universite Laval
city: Praha
country: Czechia
facility: Il. Interni klinika kardiologie a angiologie
city: Aalborg
country: Denmark
facility: Department of Cardiology Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Department of Cardiology Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: The Heart Center, Department of Cardiology
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Marseille
country: France
facility: Hopital de la Timone Service de cardiologie
city: Nantes
country: France
facility: CHU de Nantes Institut Du Thorax et du systeme nerveux Clinique Cardiologique et des Maladies Vasculaires
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Pessac
country: France
facility: Hopital cardiologique de Haut-Leveque
city: Rennes
country: France
facility: Centre hospitalier universitaire (CHU) de Rennes-Hopital Pontchaillou
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Goettigen
country: Germany
facility: Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie
city: Heidelberg
country: Germany
facility: Universitaesklinkum Heidelberg
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Würzburg
country: Germany
facility: Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC)
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
city: Ashkelon
country: Israel
facility: The Barzilai University Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center- Ein Kerem
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
city: Firenze
country: Italy
facility: Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
city: Pisa
country: Italy
facility: Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo
city: Roma
country: Italy
facility: Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center (MUMC)
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center Department of Cardiology
city: Katowice
country: Poland
facility: Kardio Brynow S.C.
city: Warszawa
country: Poland
facility: Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca
city: Aveiro
country: Portugal
facility: Centro Hospitalar Do Baixo Vouga, EPE Cardiology Department
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Madrid
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
city: Palma
country: Spain
facility: Hospital Universitario Son Llatzer
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena-merge
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility Neuroscience Institute
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Oxford
country: United Kingdom
facility: Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford
Study officials:
affiliation: Cytokinetics
name: Cytokinetics, MD
role: STUDY_DIRECTOR
References: