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CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for Aficamten (CK-3773274) (FOREST-HCM)

Primary Purpose

Symptomatic Hypertrophic Cardiomyopathy (HCM)

Status
Enrolling by invitation
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CK-3773274 (5 - 20 mg)
Sponsored by
Cytokinetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Hypertrophic Cardiomyopathy (HCM) focused on measuring Obstructive Hypertrophic Cardiomyopathy, oHCM, CK-3773274, CK-274, Non obstructive hypertrophic cardiomyopathy, nHCM, HCM, Hypertrophic cardiomyopathy, Aficamten, REDWOOD-OLE, CY 6022, FOREST-HCM, Forest

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Has taken any investigational study drug other than CK-3773274 within 30 days prior to screening

  • 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.
  • Has current obstructive coronary artery disease (>70% stenosis documented in one or more arteries)
  • Has moderate or severe aortic valve stenosis
  • Had a confirmed LVEF <40% with an associated dose interruption during CY 6021
  • History of syncope or sustained ventricular tachyarrhythmia with exercise within 30 days prior to screening
  • History of appropriate ICD shock within 30 days prior to screening
  • Has received treatment with mavacamten

Sites / Locations

  • Alaska Heart and Vascular Institute
  • Cedar-Sinai Medical Center
  • Cedars-Sinai Medical Center (Smidt Heart Institute)
  • UCSF Medical Center
  • Yale New Haven Hospital
  • MedStar Washington Hospital Center
  • Holy Cross Hospital / Cardiology Associates
  • Northwestern University
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Michigan Medicine - University of Michigan
  • University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)
  • Saint Luke's Hospital of Kansas City
  • Morristown Medical Center
  • NYU Langone Health
  • Columbia University Medical Center/New York Presbyterian Hospital
  • Sanger Heart & Vascular Institute - HCM Clinic
  • Duke Cardiology at Southpoint
  • Cleveland Clinic
  • Oregon Health & Science University
  • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
  • UPMC Presbyterian
  • Vanderbilt University Medical Center
  • The University of Texas Southwestern Medical Center at Dallas
  • Houston Methodist Hospital
  • University of Utah Health
  • University of Virginia Health System University Hospital
  • The Heart Center, Department of Cardiology
  • Copenhagen University Hospital
  • Hopital de la Timone Service de cardiologie
  • CHU de Nantes Institut Du Thorax et du systeme nerveux Clinique Cardiologique et des Maladies Vasculaires
  • Hopital Lariboisiere
  • Hopital Europeen Georges Pompidou
  • Hopital cardiologique de Haut-Leveque
  • Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie
  • Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC)
  • Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
  • The Barzilai University Medical Center
  • Hadassah Medical Center- Ein Kerem
  • The Chaim Sheba Medical Center
  • Ziv Medical Center
  • Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
  • Maastricht University Medical Center (MUMC)
  • Erasmus Medical Center Department of Cardiology
  • Kardio Brynow S.C.
  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca
  • Complejo Hospitalario Universitario A Coruna
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Clinico Universitario Virgen de la Arrixaca
  • Hospital Universitario de Salamanca
  • Hospital Universitario Virgen Macarena-merge
  • Glasgow Clinical Research Facility Neuroscience Institute
  • Liverpool Heart and Chest Hospital
  • St Bartholomew's Hospital
  • Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CK-3773274 up to 20 mg

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of adverse events observed during dosing of CK-3773274 in patients with HCM
Patient incidence of reported Adverse Events (AEs)

Secondary Outcome Measures

Incidence of serious adverse events observed during dosing of CK-3773274 in patients with HCM
Patient incidence of reported Serious Adverse Events (SAEs)
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with HCM
Patient incidence of reported LVEF <50%
Long-term effects of CK-3773274 on left ventricular outflow tract gradient (LVOT G) in patients with oHCM
Peak LVOT-G at rest

Full Information

First Posted
April 9, 2021
Last Updated
September 1, 2023
Sponsor
Cytokinetics
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1. Study Identification

Unique Protocol Identification Number
NCT04848506
Brief Title
CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for Aficamten (CK-3773274)
Acronym
FOREST-HCM
Official Title
A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment of Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytokinetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CK-3773274 up to 20 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CK-3773274 (5 - 20 mg)
Intervention Description
CK-3773274 tablets administered orally
Primary Outcome Measure Information:
Title
Incidence of adverse events observed during dosing of CK-3773274 in patients with HCM
Description
Patient incidence of reported Adverse Events (AEs)
Time Frame
Baseline to End of study, up to 5 years
Secondary Outcome Measure Information:
Title
Incidence of serious adverse events observed during dosing of CK-3773274 in patients with HCM
Description
Patient incidence of reported Serious Adverse Events (SAEs)
Time Frame
Baseline to End of study, up to 5 years
Title
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with HCM
Description
Patient incidence of reported LVEF <50%
Time Frame
Baseline to End of study, up to 5 years
Title
Long-term effects of CK-3773274 on left ventricular outflow tract gradient (LVOT G) in patients with oHCM
Description
Peak LVOT-G at rest
Time Frame
Baseline through the end of participation at 12-week intervals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cytokinetics, MD
Organizational Affiliation
Cytokinetics
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Heart and Vascular Institute
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Cedar-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars-Sinai Medical Center (Smidt Heart Institute)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Holy Cross Hospital / Cardiology Associates
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Michigan Medicine - University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Sanger Heart & Vascular Institute - HCM Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke Cardiology at Southpoint
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia Health System University Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
The Heart Center, Department of Cardiology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Hopital de la Timone Service de cardiologie
City
Marseille
ZIP/Postal Code
130005
Country
France
Facility Name
CHU de Nantes Institut Du Thorax et du systeme nerveux Clinique Cardiologique et des Maladies Vasculaires
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital cardiologique de Haut-Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie
City
Goettigen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC)
City
Würzburg
ZIP/Postal Code
97078
Country
Germany
Facility Name
Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
The Barzilai University Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Hadassah Medical Center- Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
1311001
Country
Israel
Facility Name
Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Maastricht University Medical Center (MUMC)
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Erasmus Medical Center Department of Cardiology
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Kardio Brynow S.C.
City
Katowice
ZIP/Postal Code
40-555
Country
Poland
Facility Name
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Complejo Hospitalario Universitario A Coruna
City
Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Arrixaca
City
Madrid
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena-merge
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Glasgow Clinical Research Facility Neuroscience Institute
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for Aficamten (CK-3773274)

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