Phase
Condition
Circulation Disorders
Treatment
Non-mavacamten symptomatic oHCM therapy
Mavacamten
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
≥ 18 years of age at the time of informed consent.
Willing and able to provide written informed consent form (ICF) and any required privacy authorization prior to the initiation of study procedures (or in those situations where consent cannot be given by participants, consent provided by their legally acceptable representatives)
United States Sub-Study
Diagnosis of obstructive HCM consistent with 2020 American Heart Association/American College of Cardiology (AHA/ACC) guidelines.
Obstructive HCM is defined clinically by the presence of increased LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of HCM) in a nondilated ventricular chamber that is not solely explained by abnormal loading conditions (eg, another cardiac or systemic disease) and peak LVOT gradient of ≥ 30 mmHg at rest or with provocation.
Has documented LVEF of ≥ 55% recorded by echocardiography within the last 6 months.
Symptoms consistent with NYHA functional class II-IV.
Receiving beta blocker (BB)s, non-dihydropyridine calcium. channel blockers (nonDHP CCBs), disopyramide, and/or mavacamten (once available) as part of routine clinical care; or currently receiving no treatment due to intolerance or failure of prior treatment (eg, BBs, non-DHP CCBs, or disopyramide) for obstructive HCM.
European Sub-study
Diagnosis of obstructive HCM consistent with the most recent European Society of Cardiology (ESC) and American Heart Association/American College of Cardiology (AHA/ACC) guidelines
Documented LVEF of ≥55% recorded by TTE
Documented symptoms consistent with NYHA functional class II-III at enrollment or within 6 months prior to enrollment (if not available at enrollment).
As part of routine clinical care for obstructive HCM: receiving BBs, non-DHP CCBs, disopyramide; initiating mavacamten at enrollment; or currently receiving no treatment due to intolerance or failure of prior treatment (e.g., BBs, non-DHP CCBs, or disopyramide).
Exclusion Criteria
Known phenocopy disease (e.g., Fabry disease, amyloidosis) or LV hypertrophy associated with hypertension.
Documentation of any fixed obstruction of the outflow tract such as aortic valve stenosis or replacement.
Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to enrollment; participants with an unsuccessful myectomy or percutaneous ASA performed > 6 months prior to enrollment may be enrolled.
Naïve to treatment for obstructive HCM (ie, never treated with BBs, nonDHP CCBs, or disopyramide).
United States Sub-Study
Receiving an investigational therapeutic agent for obstructive HCM (eg, myosin-inhibitors other than mavacamten) in an interventional clinical trial at participant enrollment.
Previously or currently enrolled in a long-term safety extension study of mavacamten (eg, EXPLORER-HCM [ClinicalTrials.gov, NCT03470545], MAVA-LTE [NCT03723655], PIONEER-OLE [NCT03496168], VALORHCM [NCT04349072], or MAVERICK [NCT03442764])
European Sub-study
Receiving an investigational therapeutic agent or any cardiac myosin inhibitor and/or modulators for obstructive HCM at patient enrolment
Previously or currently enrolled in other HCM registry studies (e.g., TORCH, REMY, EU-PASS)
Previously or currently enrolled in a study of mavacamten (e.g., EXPLORER-HCM [ClinicalTrials.gov, NCT03470545], MAVA-LTE [NCT03723655], PIONEER-OLE [NCT03496168], VALOR-HCM [NCT04349072], MAVERICK [NCT03442764], or MEMENTO [NCT2264899])
Previously treated with mavacamten
Study Design
Connect with a study center
Local Institution - 0082
Braunau am Inn, 5280
AustriaSite Not Available
Local Institution - 0087
Graz, 8036
AustriaSite Not Available
Local Institution - 0088
Innsbruck, 6020
AustriaSite Not Available
Local Institution - 0084
Klagenfurt am Worthersee, 9020
AustriaSite Not Available
Local Institution - 0086
Linz, 4021
AustriaSite Not Available
Local Institution - 0085
St. Pölten, 3100
AustriaSite Not Available
Local Institution - 0083
Wien, 1090
AustriaSite Not Available
Centre Hospitalier Haguenau
Haguenau, Bas Rhin 67500
FranceActive - Recruiting
Local Institution - 0092
Haguenau, Bas Rhin 67500
FranceSite Not Available
Local Institution - 0093
Saint-Herblain, Loire Atlantique 44800
FranceSite Not Available
Local Institution - 0090
Lille, Nord 59000
FranceSite Not Available
Local Institution - 0091
Amiens Cedex 1, Somme 80054
FranceSite Not Available
Local Institution - 0094
Toulon, Var 83000
FranceSite Not Available
Local Institution - 0089
Poitiers, Vienne 86000
FranceSite Not Available
Local Institution - 0098
Aalen, Baden Wuerttemberg 73430
GermanySite Not Available
Local Institution - 0101
Erlangen, Bayern 91054
GermanySite Not Available
Local Institution - 0095
Bernau, Berlin 16321
GermanySite Not Available
Local Institution - 0100
Muenster, Nordrhein Westfalen 48149
GermanySite Not Available
Local Institution - 0099
Dresden, Sachsen 01099
GermanySite Not Available
Local Institution - 0097
Leipzig, Sachsen 04103
GermanySite Not Available
Local Institution - 0096
Berlin, 10719
GermanySite Not Available
Local Institution - 0077
Ponce, 00717-1322
Puerto RicoSite Not Available
Research & Cardiovascular Corp
Ponce, 00717-1322
Puerto RicoActive - Recruiting
Local Institution - 0106
Oviedo, Asturias 33011
SpainSite Not Available
Local Institution - 0109
Palma De Mallorca, Baleares 07198
SpainSite Not Available
Local Institution - 0104
Majadahonda, Madrid 28222
SpainSite Not Available
Local Institution - 0105
El Palmar, Murcia 30120
SpainSite Not Available
Local Institution - 0107
Burgos, 09006
SpainSite Not Available
Local Institution - 0102
Madrid, 28007
SpainSite Not Available
Local Institution - 0108
Madrid, 28040
SpainSite Not Available
Local Institution - 0103
Malaga, 29010
SpainSite Not Available
Local Institution - 0113
London, Greater London SW3 6NP
United KingdomSite Not Available
Local Institution - 0115
London, Greater London W6 8RF
United KingdomSite Not Available
Local Institution - 0112
Manchester, Greater Manchester M13 9WL
United KingdomSite Not Available
Local Institution - 0111
Liverpool, Merseyside L14 3PE
United KingdomSite Not Available
Local Institution - 0110
Birmingham, West Midlands B15 2GW
United KingdomSite Not Available
Local Institution - 0114
Leeds, West Yorkshire LS1 3EX
United KingdomSite Not Available
Local Institution - 0116
Cardiff, CF14 4XW
United KingdomSite Not Available
Alaska Heart Institute
Anchorage, Alaska 99508
United StatesActive - Recruiting
Local Institution - 0074
Phoenix, Arizona 85054
United StatesSite Not Available
Mayo Clinic - Arizona
Phoenix, Arizona 85054
United StatesSite Not Available
Pima Heart and Vascular
Tucson, Arizona 85704
United StatesActive - Recruiting
UAMS
Little Rock, Arkansas 72205-7199
United StatesActive - Recruiting
UC San Diego School of Medicine
La Jolla, California 92037
United StatesActive - Recruiting
Keck School of Medicine of USC-Usc
Los Angeles, California 90033
United StatesActive - Recruiting
Local Institution - 0020
Los Angeles, California 90048
United StatesSite Not Available
Local Institution - 0012
Palo Alto, California 94304
United StatesSite Not Available
Stanford Health Care Hospital & Clinics
Palo Alto, California 94304
United StatesActive - Recruiting
Eisenhower Medical Center.
Rancho Mirage, California 92270
United StatesSite Not Available
Local Institution - 0061
Rancho Mirage, California 92270
United StatesSite Not Available
Local Institution - 0060
Sacramento, California 95817
United StatesSite Not Available
University Of California San Francisco Medical Center
San Francisco, California 94117
United StatesActive - Recruiting
Local Institution - 0050
Aurora, Colorado 48377
United StatesSite Not Available
UC Denver, AMC
Aurora, Colorado 48377
United StatesActive - Recruiting
Hartford HealthCare
Hartford, Connecticut 06106
United StatesActive - Recruiting
Local Institution - 0081
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesActive - Recruiting
Local Institution - 0071
Jacksonville, Florida 32224
United StatesSite Not Available
Uf Health Jacksonville
Jacksonville, Florida 32209
United StatesActive - Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
United StatesActive - Recruiting
University of Chicago Dept of Medicine
Chicago, Illinois 60637
United StatesActive - Recruiting
Local Institution - 0079
Kankakee, Illinois 60901
United StatesSite Not Available
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis, Indiana 46237
United StatesActive - Recruiting
Indiana. University
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Local Institution - 0045
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
University Of Kansas Medical Center & Medical Pavilion
Kansas City, Kansas 66160
United StatesActive - Recruiting
Local Institution - 0059
Baltimore, Maryland 21201
United StatesSite Not Available
MedStar Health Research Institute
Baltimore, Maryland 21218
United StatesActive - Recruiting
University Of Maryland, Ihv
Baltimore, Maryland 21201
United StatesActive - Recruiting
Harvard (Massachusetts General Hospital)
Boston, Massachusetts 02114
United StatesActive - Recruiting
Harvard Medical School - Brigham and Women's Hospital (BWH)
Boston, Massachusetts 02215
United StatesActive - Recruiting
Local Institution - 0014
Ann Arbor, Michigan 48109
United StatesSite Not Available
Spectrum Health Medical Group
Grand Rapids, Michigan 49525
United StatesActive - Recruiting
Local Institution - 0049
Novi, Michigan 48377
United StatesSite Not Available
Henry Ford Health System
West Bloomfield, Michigan 48322
United StatesActive - Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
Cardiology Associates Research, Llc
Tupelo, Mississippi 38801
United StatesActive - Recruiting
Local Institution - 0069
Kansas City, Missouri 64111
United StatesSite Not Available
St. Luke's Mid-America Heart Institute
Kansas City, Missouri 64111
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
CHI Health Reseach Center
Omaha, Nebraska 68124
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Local Institution - 0026
Morristown, New Jersey 07960
United StatesSite Not Available
Morristown Medical Center
Morristown, New Jersey 07960
United StatesActive - Recruiting
Local Institution - 0078
New Brunswick, New Jersey 08901
United StatesSite Not Available
Rutgers- Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United StatesSite Not Available
Bassett Medical Center
Cooperstown, New York 13326
United StatesActive - Recruiting
Northwell Health
Manhasset, New York 11030
United StatesActive - Recruiting
Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
Mount Sinai West
New York, New York 10019
United StatesActive - Recruiting
Saint Francis Hospital
Roslyn, New York 11576
United StatesActive - Recruiting
WMCHealth Advanced Physician Services
Valhalla, New York 10595
United StatesActive - Recruiting
Westchester Medical Center
Valhalla, New York 10595
United StatesActive - Recruiting
Focus Clinical Research
Charlotte, North Carolina 28207
United StatesActive - Recruiting
Local Institution - 0072
Charlotte, North Carolina 28203
United StatesSite Not Available
Duke University Health System
Durham, North Carolina 27710
United StatesActive - Recruiting
Christ Hospital Health Network
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Local Institution - 0038
Portland, Oregon 97239
United StatesSite Not Available
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United StatesActive - Recruiting
Lancaster General Hospital
Lancaster, Pennsylvania 17603
United StatesActive - Recruiting
Local Institution - 0031
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
AHN
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
University Of Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Geisinger Health System
Wilkes-Barre, Pennsylvania 18711
United StatesActive - Recruiting
Local Institution - 0066
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Prisma Health - Upstate
Greenville, South Carolina 29605
United StatesActive - Recruiting
Local Institution - 0019
Nashville, Tennessee 37205-2018
United StatesSite Not Available
Saint Thomas Health
Nashville, Tennessee 37205-2018
United StatesActive - Recruiting
Tristar Centennial Medical Ctr
Nashville, Tennessee 37203
United StatesActive - Recruiting
Baylor Scott & White Research Institute
Dallas, Texas 75246
United StatesActive - Recruiting
North Texas Cardiology Center
Dallas, Texas 75208
United StatesActive - Recruiting
BI Research Center
Houston, Texas 77084
United StatesActive - Recruiting
Baylor St. Luke's Medical Center
Houston, Texas 77030
United StatesSite Not Available
Local Institution - 0005
Houston, Texas 77030
United StatesSite Not Available
The Methodist Hospital, Methodist Cancer Cencer
Houston, Texas 77030
United StatesActive - Recruiting
Baylor Scott & White The Heart Hospital Plano
Plano, Texas 75093
United StatesActive - Recruiting
Local Institution - 0028
Plano, Texas 75093
United StatesSite Not Available
Baylor Scott & White Medical Centre - Temple
Temple, Texas 76508
United StatesActive - Recruiting
The Rector and Visitors of the Univ of Virginia
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Local Institution - 0064
Norfolk, Virginia 23504
United StatesSite Not Available
Sentara Healthcare
Norfolk, Virginia 23504
United StatesSite Not Available
VCU Medical Center
Richmond, Virginia 23298
United StatesActive - Recruiting
Carilion Clinic; Virginia Tech-Carilion School of Medicine
Roanoke, Virginia 24014
United StatesActive - Recruiting
Local Institution - 0032
Seattle, Washington 98195
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesActive - Recruiting
WVU Hospitals
Morgantown, West Virginia 26506
United StatesActive - Recruiting
University Of Wisconsin - Madison
Madison, Wisconsin 53792
United StatesActive - Recruiting
Local Institution - 0054
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin, Inc (PI Address)
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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