Back to resultsCY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCM (SEQUOIA-HCM)
Primary Purpose
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg)
Placebo to match CK-3773274
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Hypertrophic Cardiomyopathy (oHCM) focused on measuring Obstructive Hypertrophic Cardiomyopathy, oHCM, CK-3773274, CK-274, Aficamten, SEQUOIA-HCM, CY 6031, SEQUOIA
Eligibility Criteria
Key Inclusion Criteria:
- Males and females between 18 and 85 years of age, inclusive, at screening.
- Body mass index <35 kg/m2.
Diagnosed with HCM per the following criteria:
- Has LV hypertrophy and 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 of:
- ≥15 mm in one or more myocardial segments OR
- ≥13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM
- Has resting LVOT-G ≥30 mmHg and post-Valsalva LVOT G ≥50 mmHg during screening as determined by the echocardiography core laboratory.
- LVEF ≥60% at screening as determined by the echocardiography core laboratory.
- NYHA Functional Class II or III at screening.
- Hemoglobin ≥10g/dL at screening.
- Respiratory exchange ratio (RER) ≥1.05 and pVO2 <80% predicted on the screening CPET per the core laboratory.
- Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for >6 weeks prior to randomization and anticipate remaining on the same medication regimen during the trial. Patients treated with disopyramide must also be concomitantly treated with a beta blocker and/or calcium channel blocker.
Key Exclusion Criteria:
- Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
Significant valvular heart disease (per investigator judgment).
- Moderate-severe valvular aortic stenosis.
- Moderate-severe mitral regurgitation not due to systolic anterior motion of the mitral valve.
- 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).
- Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the trial period.
- Documented paroxysmal atrial fibrillation during the screening period.
- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months.)
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
- Has received prior treatment with CK-3773274 or mavacamten.
Sites / Locations
- Alaska Heart and Vascular Institute
- UC San Diego Health - Sulpizio Cardiovascular Center
- Cedars-Sinai Medical Center - Smidt Heart Institute Clinic
- University of California San Francisco
- Stanford University Hospital
- Yale School of Medicine
- Yale University School of Medicine
- MedStar Washington Hospital Center
- Holy Cross Hospital / Cardiology Associates
- Mayo Clinic Florida
- Emory Clinic
- Piedmont Fayette Hospital
- Northwestern University
- University of Iowa
- MedStar Medical Group Cardiology at Union Memorial
- Medstar Franklin Square Medical Center
- Massachusetts General Hospital
- Brigham and Women's Hospital
- Lahey Hospital & Medical Center
- Michigan Medicine
- Henry Ford Medical Center
- Spectrum Health Medical Group Cardiovascular Medicine
- M Health Fairview University of Minnesota Medical Center - East Bank
- Mayo Clinic
- Saint Luke's Hospital of Kansas City
- Washington University School of Medicine
- Morristown Medical Center
- NYU Langone Health
- Mount Sinai Hospital
- Columbia University Medical Center/NY Presbyterian Hospital
- Westchester Medical Center
- Sanger Heart and Vascular Institute
- Sanger Heart and Vascular Institute - HCM Clinic
- Duke Health Center Arringdon
- Cleveland Clinic
- The Ohio State University Wexner Medical Center
- Ascension St. John Clinical Research Institute
- Oregon Health & Science University
- Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
- UPMC Presbyterian
- Stern Cardiovascular Foundation, Inc
- Vanderbilt University Medical Center
- The University of Texas Southwestern Medical Center
- Houston Methodist Hospital
- University of Utah Hospital
- University of Virginia Health System University Hospital
- University of Washington Medical
- Froedtert Hospital
- Beijing Chao-Yang Hospital, Capital Medical University
- Beijing Anzhen Hospital
- Peking University Third Hospital
- Nanfang Hospital Southern Medical University
- The First Affiliated Hospital of Zhengzhou University
- Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
- Xiangya Hospital of the Central South University
- The First Hospital of Jinlin University
- The First Affiliated Hospital of Xi'an Jiaotong University
- Charles University
- Interni klinika kardiologie a angiologie
- Aalborg University Hospital, Department of Cardiology
- Department of Cardiology Aarhus University Hospital
- Hjertecentret (The Heart Center)
- Copenhagen University Hospital
- Hopital Universitaire de Rangueil (CHU de Toulouse) Service de Cardiologie
- CHU de Marseille - Hopital de la Timone Service de cardiologie
- CHU de Nantes
- CHU de Nantes
- Hopital Lariboisiere, Service de Cardiologie
- Hôpital Européen Georges Pompidou
- CHU Pitie-Salpetriere, Centre de reference maladies cardiaques hereditaires ou rares
- CHU de Bordeaux Hopital Cardiologique Haut-Leveque
- CHU du Haut Lveque Cardiologie
- Kerckhoff-Klinik GmbH Abteilung Administration Forschung und Lehre
- Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie
- Universitaetsklinikum Essen Westdeutsches Herz-Gefaesszentrum
- Universitaetsmedizin Goettingen
- Klinikumder Georg-August-Universitaet
- Universitaetsklinikum Heidelberg
- Universitaetsklinikum Jena Klinik fuer Innere Medizin 1
- Unniversitaetsklinikum Magdeburg Klinik fur Kardiologie und Anglologie
- Universitätsklinikum Würzburg
- Semmelweis Egyetem Varosmajori Sziv es Ergyogyasazati Klinika
- The Olga & Lev Leviev Heart Center The Chaim Sheba Medical Center
- The Barzilai University Medical Center
- The Barzilai University Medical Center
- Hadassah Medical Center- Ein Kerem
- Kaplan Medical Center
- Ziv Medical Center
- UOC Cardiologica Azienda Ospedaliera Spedali Civili di Brescia
- Azienda Ospedaliero Universitaria Careggi Dipartimento Cardiotoracovascolare - Cardiomiopatie Unit
- Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo
- Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea
- Amsterdam UMC, location AMC
- University Hospital Maastricht
- Erasmus Medical Center
- Narodowy Instytut Kardiologii Stefana Kardynała Wyszynskiego- Panstwowy Instytut Badawczy
- Kardio Brynow S.C
- Krakowskie Centrum
- Centro Hospitalar Do Baixo Vouga, EPE AV ARTUR RAVARA
- Hospital da Luz
- Complejo Hospitalario Universitario
- Hospital Universitario Puerta de Hierro
- Hospital Clinic de Barcelona
- Hospital Clinico Universitario Virgen de la Arrixaca
- Hospital Universitario Son Llatzer Secretaria de Cardiologia
- Hospital Universitario de Salamanca
- Hospital Universitario Virgen Macarena-merge
- Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust
- Queen Elizabeth University Hospital - HWS Greater Glasgow and Clyde
- Liverpool Heart and Chest Hospital - Liverpool Heart and Chest Hospital NHS Foundation Trust- HWS Greater Glasgow and Clyde
- Barts Health NS Trust
- St George's University Hospitals NHS Foundation Trust
- Royal Brompton Hospital
- Oxford Centre for Clinical Magnetic Resonance Research
- Radcliffe Department of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CK-3773274 up to 20 mg
Placebo to match CK-3773274
Arm Description
Patients will receive doses of 5 mg, 10 mg, 15 mg or 20 mg of CK-3773274 with dose levels guided by echocardiography assessments for up to 24 weeks
Patients will receive placebo for up to 24 weeks
Outcomes
Primary Outcome Measures
Change in peak oxygen uptake (pVO2) by cardiopulmonary exercise testing (CPET)
Effect of CK-3773274 on exercise capacity in patients with symptomatic oHCM
Secondary Outcome Measures
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Effect of CK-3773274 on patient health status
Proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) Functional Class
Effect of CK-3773274 on NYHA Functional Classification
Change in post-Valsalva left ventricular outflow tract gradients (LVOT-G)
Effect of CK-3773274 on post-Valsalva LVOT-G
Proportion of patients with post-Valsalva LVOT G <30 mmHg
Effect of CK-3773274 on post-Valsalva LVOT-G
Change in total workload during CPET
Effect of CK-3773274 on exercise capacity
Duration of eligibility for septal reduction therapy (SRT)
Effect of CK-3773274 on duration of eligibility for septal reduction therapy
Full Information
NCT ID
NCT05186818
First Posted
December 23, 2021
Last Updated
September 1, 2023
Sponsor
Cytokinetics
Collaborators
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05186818
Brief Title
CY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCM
Acronym
SEQUOIA-HCM
Official Title
A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytokinetics
Collaborators
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Keywords
Obstructive Hypertrophic Cardiomyopathy, oHCM, CK-3773274, CK-274, Aficamten, SEQUOIA-HCM, CY 6031, SEQUOIA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CK-3773274 up to 20 mg
Arm Type
Experimental
Arm Description
Patients will receive doses of 5 mg, 10 mg, 15 mg or 20 mg of CK-3773274 with dose levels guided by echocardiography assessments for up to 24 weeks
Arm Title
Placebo to match CK-3773274
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo for up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg)
Intervention Description
CK-3773274 tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo to match CK-3773274
Intervention Description
Placebo administered orally
Primary Outcome Measure Information:
Title
Change in peak oxygen uptake (pVO2) by cardiopulmonary exercise testing (CPET)
Description
Effect of CK-3773274 on exercise capacity in patients with symptomatic oHCM
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Description
Effect of CK-3773274 on patient health status
Time Frame
Baseline to Week 12 and Week 24
Title
Proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) Functional Class
Description
Effect of CK-3773274 on NYHA Functional Classification
Time Frame
Baseline to Week 12 and Week 24
Title
Change in post-Valsalva left ventricular outflow tract gradients (LVOT-G)
Description
Effect of CK-3773274 on post-Valsalva LVOT-G
Time Frame
Baseline to Week 12 and Week 24
Title
Proportion of patients with post-Valsalva LVOT G <30 mmHg
Description
Effect of CK-3773274 on post-Valsalva LVOT-G
Time Frame
Baseline to Week 12 and Week 24
Title
Change in total workload during CPET
Description
Effect of CK-3773274 on exercise capacity
Time Frame
Baseline to Week 24
Title
Duration of eligibility for septal reduction therapy (SRT)
Description
Effect of CK-3773274 on duration of eligibility for septal reduction therapy
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Males and females between 18 and 85 years of age, inclusive, at screening.
Body mass index <35 kg/m2.
Diagnosed with HCM per the following criteria:
Has LV hypertrophy and 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 of:
≥15 mm in one or more myocardial segments OR
≥13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM
Has resting LVOT-G ≥30 mmHg and post-Valsalva LVOT G ≥50 mmHg during screening as determined by the echocardiography core laboratory.
LVEF ≥60% at screening as determined by the echocardiography core laboratory.
NYHA Functional Class II or III at screening.
Hemoglobin ≥10g/dL at screening.
Respiratory exchange ratio (RER) ≥1.05 and pVO2 ≤90% predicted on the screening CPET per the core laboratory.
Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for >6 weeks prior to randomization and anticipate remaining on the same medication regimen during the trial. Patients treated with disopyramide must also be concomitantly treated with a beta blocker and/or calcium channel blocker.
Key Exclusion Criteria:
Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
Significant valvular heart disease (per investigator judgment).
Moderate-severe valvular aortic stenosis.
Moderate-severe mitral regurgitation not due to systolic anterior motion of the mitral valve.
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).
Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the trial period.
Documented paroxysmal atrial fibrillation during the screening period.
Paroxysmal or permanent atrial fibrillation is only excluded IF:
rhythm restoring treatment (eg, direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤6 months prior to screening.
rate control and anticoagulation have not been achieved for at least 6 months prior to screening.
History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
Has received prior treatment with CK-3773274 or mavacamten.
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
UC San Diego Health - Sulpizio Cardiovascular Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cedars-Sinai Medical Center - Smidt Heart Institute Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Yale University School of Medicine
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
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Piedmont Fayette Hospital
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
MedStar Medical Group Cardiology at Union Memorial
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Medstar Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
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
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Spectrum Health Medical Group Cardiovascular Medicine
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
M Health Fairview University of Minnesota Medical Center - East Bank
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
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
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center/NY Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Sanger Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
10595
Country
United States
Facility Name
Sanger Heart and Vascular Institute - HCM Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke Health Center Arringdon
City
Morrisville
State/Province
North Carolina
ZIP/Postal Code
27560
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ascension St. John Clinical Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
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
Stern Cardiovascular Foundation, Inc
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
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
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 Hospital
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
University of Washington Medical
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10019
Country
China
Facility Name
Nanfang Hospital Southern Medical University
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
516006
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450018
Country
China
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Xiangya Hospital of the Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The First Hospital of Jinlin University
City
Changchun
State/Province
Jinlin
ZIP/Postal Code
130031
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Charles University
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Interni klinika kardiologie a angiologie
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Aalborg University Hospital, Department of Cardiology
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Department of Cardiology Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Hjertecentret (The Heart Center)
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Hopital Universitaire de Rangueil (CHU de Toulouse) Service de Cardiologie
City
Toulouse
State/Province
Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Marseille - Hopital de la Timone Service de cardiologie
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU de Nantes
City
Nantes Cedex
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Lariboisiere, Service de Cardiologie
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHU Pitie-Salpetriere, Centre de reference maladies cardiaques hereditaires ou rares
City
Paris
Country
France
Facility Name
CHU de Bordeaux Hopital Cardiologique Haut-Leveque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
CHU du Haut Lveque Cardiologie
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Kerckhoff-Klinik GmbH Abteilung Administration Forschung und Lehre
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Essen Westdeutsches Herz-Gefaesszentrum
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsmedizin Goettingen
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Klinikumder Georg-August-Universitaet
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitaetsklinikum Jena Klinik fuer Innere Medizin 1
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Unniversitaetsklinikum Magdeburg Klinik fur Kardiologie und Anglologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Facility Name
Semmelweis Egyetem Varosmajori Sziv es Ergyogyasazati Klinika
City
Budapest
Country
Hungary
Facility Name
The Olga & Lev Leviev Heart Center The Chaim Sheba Medical Center
City
Ramat Gan
State/Province
Tel Hasomer
ZIP/Postal Code
5265601
Country
Israel
Facility Name
The Barzilai University Medical Center
City
Ashkelon
ZIP/Postal Code
78100
Country
Israel
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
Kaplan Medical Center
City
Reẖovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Ziv Medical Center
City
Zefat
ZIP/Postal Code
13100
Country
Israel
Facility Name
UOC Cardiologica Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi Dipartimento Cardiotoracovascolare - Cardiomiopatie Unit
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea
City
Roma
ZIP/Postal Code
1035-39
Country
Italy
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6229HX
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Narodowy Instytut Kardiologii Stefana Kardynała Wyszynskiego- Panstwowy Instytut Badawczy
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Kardio Brynow S.C
City
Katowice
Country
Poland
Facility Name
Krakowskie Centrum
City
Kraków
Country
Poland
Facility Name
Centro Hospitalar Do Baixo Vouga, EPE AV ARTUR RAVARA
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Hospital da Luz
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Complejo Hospitalario Universitario
City
A Coruña
State/Province
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
State/Province
Majadahonda
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Universitario Son Llatzer Secretaria de Cardiologia
City
Palma
ZIP/Postal Code
07198
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
Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital - HWS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G1 4TF
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital - Liverpool Heart and Chest Hospital NHS Foundation Trust- HWS Greater Glasgow and Clyde
City
Liverpool
ZIP/Postal Code
L14 3LB
Country
United Kingdom
Facility Name
Barts Health NS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
St George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Oxford Centre for Clinical Magnetic Resonance Research
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Radcliffe Department of Medicine
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
CY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCM
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