A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)
NCT ID: NCT05489705
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1600 participants
OBSERVATIONAL
2022-08-16
2029-08-17
Brief Summary
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United States Sub-Study: The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting.
Europe Sub-Study: The purpose of this study is to evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mavacamten
Participants will receive mavacamten as prescribed by a physician according to standard of care for symptomatic oHCM
Mavacamten
As per product label
Beta-blocker (BB) / non-dihydropyridine (non-DHP) calcium channel blocker (CCB) / disopyramide
Participants will receive BB/non-DHP CCB/disopyramide as prescribed by a physician according to standard of care for symptomatic oHCM
Non-mavacamten symptomatic oHCM therapy
Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label
Interventions
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Mavacamten
As per product label
Non-mavacamten symptomatic oHCM therapy
Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Alaska Heart Institute
Anchorage, Alaska, United States
Pima Heart and Vascular
Tucson, Arizona, United States
UAMS
Little Rock, Arkansas, United States
UC San Diego School of Medicine
La Jolla, California, United States
Keck School of Medicine of USC-Usc
Los Angeles, California, United States
Stanford Health Care Hospital & Clinics
Palo Alto, California, United States
University Of California San Francisco Medical Center
San Francisco, California, United States
UC Denver, AMC
Aurora, Colorado, United States
Hartford HealthCare
Hartford, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Uf Health Jacksonville
Jacksonville, Florida, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
University of Chicago Dept of Medicine
Chicago, Illinois, United States
Indiana. University
Indianapolis, Indiana, United States
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University Of Kansas Medical Center & Medical Pavilion
Kansas City, Kansas, United States
University Of Maryland, Ihv
Baltimore, Maryland, United States
MedStar Health Research Institute
Baltimore, Maryland, United States
Harvard (Massachusetts General Hospital)
Boston, Massachusetts, United States
Harvard Medical School - Brigham and Women's Hospital (BWH)
Boston, Massachusetts, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, United States
Henry Ford Health System
West Bloomfield, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Cardiology Associates Research, Llc
Tupelo, Mississippi, United States
St. Luke's Mid-America Heart Institute
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
CHI Health Reseach Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Bassett Medical Center
Cooperstown, New York, United States
Northwell Health
Manhasset, New York, United States
Mount Sinai West
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Saint Francis Hospital
Roslyn, New York, United States
WMCHealth Advanced Physician Services
Valhalla, New York, United States
Focus Clinical Research
Charlotte, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Christ Hospital Health Network
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States
Geisinger Health System
Wilkes-Barre, Pennsylvania, United States
Prisma Health - Upstate
Greenville, South Carolina, United States
Tristar Centennial Medical Ctr
Nashville, Tennessee, United States
Saint Thomas Health
Nashville, Tennessee, United States
North Texas Cardiology Center
Dallas, Texas, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
The Methodist Hospital, Methodist Cancer Cencer
Houston, Texas, United States
BI Research Center
Houston, Texas, United States
Baylor Scott & White The Heart Hospital Plano
Plano, Texas, United States
Baylor Scott & White Medical Centre - Temple
Temple, Texas, United States
The Rector and Visitors of the Univ of Virginia
Charlottesville, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
Carilion Clinic; Virginia Tech-Carilion School of Medicine
Roanoke, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
WVU Hospitals
Morgantown, West Virginia, United States
University Of Wisconsin - Madison
Madison, Wisconsin, United States
Medical College of Wisconsin, Inc (PI Address)
Milwaukee, Wisconsin, United States
KH St.Josef Braunau am Inn
Braunau am Inn, , Austria
LKH-Univ. Klinikum Graz
Graz, , Austria
Local Institution - 0088
Innsbruck, , Austria
Local Institution - 0084
Klagenfurt, , Austria
Kepler Universitätsklinikum Linz
Linz, , Austria
Local Institution - 0085
Sankt Pölten, , Austria
Local Institution - 0083
Vienna, , Austria
Centre Hospitalier Haguenau
Haguenau, Bas Rhin, France
CHU Nantes Hopital Nord Laennec
Saint-Herblain, Loire Atlantique, France
Hôpital Saint Vincent-de-Paul
Lille, Nord, France
CHU Amiens-Picardie
Amiens, Somme, France
Hôpital Sainte Musse
Toulon, Var, France
CHU De Poitiers - Hopital De La Miletrie
Poitiers, Vienne, France
Local Institution - 0117
Montpellier, , France
Ostalb-Klinikum Aalen
Aalen, Baden-Wurttemberg, Germany
Local Institution - 0101
Erlangen, Bavaria, Germany
Universitatsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
Praxisklinik Herz Und Gefasse-Klinikum Weisser Hirsch
Dresden, Saxony, Germany
Universitaetsklinikum Leipzig Aoer
Leipzig, Saxony, Germany
Immanuel Klinikum Bernau
Bernau, State of Berlin, Germany
Kardiologische und angiologische Praxen im Spreebogen
Berlin, , Germany
Research & Cardiovascular Corp
Ponce, , Puerto Rico
Hospital Fundacion Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario de Burgos
Burgos, , Spain
Local Institution - 0102
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Clinico Universitario Virgen de La Victoria
Málaga, , Spain
Local Institution - 0113
London, Greater London, United Kingdom
Imperial College Healthcare NHS Trust
London, Greater London, United Kingdom
University Of Manchester
Manchester, Greater Manchester, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Leeds General Infirmary
Leeds, West Yorkshire, United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Ahmed Abuzaid, Site 0023
Role: primary
Greg Koshkarian, Site 0025
Role: primary
Srikanth Vallurupalli, Site 0007
Role: primary
Jorge Silva Enciso, Site 0037
Role: primary
Eugene DePasquale, Site 0057
Role: primary
Matthew Wheeler, Site 0012
Role: primary
Theodore Abraham, Site 0021
Role: primary
David Raymer, Site 0050
Role: primary
Adaya Weissler-Snir, Site 0067
Role: primary
Patrick Bering, Site 0081
Role: primary
Andres Pineda, Site 0065
Role: primary
Dipanjan Banerjee, Site 0046
Role: primary
Gene Kim, Site 0063
Role: primary
Roopa Rao, Site 0013
Role: primary
George Lolay, Site 0016
Role: primary
Ernesto Ruiz Duque, Site 0045
Role: primary
Loren Berenbom, Site 0033
Role: primary
Manjula Ananthram, Site 0059
Role: primary
Sandeep Jani, Site 0030
Role: primary
Albree Tower-Rader, Site 0024
Role: primary
Carolyn Ho, Site 0068
Role: primary
David Fermin, Site 0073
Role: primary
Karthikeyan Ananthasubramaniam, Site 0034
Role: primary
Robert Fraser, Site 0010
Role: primary
Barry Bertolet, Site 0062
Role: primary
Michael Nassif, Site 0069
Role: primary
Richard Bach, Site 0036
Role: primary
Amjad Kabach, Site 0070
Role: primary
Dmitry Nemirovsky, Site 0029
Role: primary
Matthew Martinez, Site 0026
Role: primary
Mun Hong, Site 0006
Role: primary
Ronald Wharton, Site 0001
Role: primary
Kim Kim, Site 0009
Role: primary
Johanna Contreras, Site 0035
Role: primary
Allen Jeremias, Site 0075
Role: primary
Srihari Naidu, Site 0053
Role: primary
Aamer Qurehshi, Site 0040
Role: primary
Andrew Wang, Site 0022
Role: primary
Wojciech Mazur, Site 0015
Role: primary
Anene Clair Ukaigwe, Site 0041
Role: primary
Milind Desai, Site 0003
Role: primary
Jamshid Shirani, Site 0043
Role: primary
Robert Donovan, Site 0076
Role: primary
Craig Alpert, Site 0002
Role: primary
Timothy Wong, Site 0027
Role: primary
Vernon Mascarenhas, Site 0056
Role: primary
Josh Doll, Site 0042
Role: primary
Bryan Doherty, Site 0048
Role: primary
Mark Zenker, Site 0019
Role: primary
Manavjot Sidhu, Site 0018
Role: primary
Robert Gottlieb, Site 0008
Role: primary
Sherif Nagueh, Site 0058
Role: primary
Asif Akhtar, Site 0039
Role: primary
David Rawitscher, Site 0028
Role: primary
Vinh Nguyen, Site 0051
Role: primary
Christopher Kramer, Site 0011
Role: primary
Mohammed Makkiya, Site 0080
Role: primary
Ali Hama Amin, Site 0044
Role: primary
Mariko Harper, Site 0052
Role: primary
Christopher Bianco, Site 0055
Role: primary
Ravi Dhingra, Site 0004
Role: primary
Abhinav Sharma, Site 0054
Role: primary
Johann Auer, Site 0082
Role: primary
Nicolas Verheyen, Site 0087
Role: primary
Site 0088
Role: primary
Christian Reiter, Site 0086
Role: primary
Site 0085
Role: primary
Site 0083
Role: primary
Charlotte Dagrenat, Site 0092
Role: primary
Nicolas Piriou, Site 0093
Role: primary
Ludovic Appert, Site 0090
Role: primary
Yohann Bohbot, Site 0091
Role: primary
Jean-Michel Tartière, Site 0094
Role: primary
Benjamin Alos, Site 0089
Role: primary
Stephanie Loebig, Site 0098
Role: primary
Jürgen Sindermann, Site 0100
Role: primary
Gregor Simonis, Site 0099
Role: primary
Karsten Lenk, Site 0097
Role: primary
Christian Butter, Site 0095
Role: primary
Wilhelm Haverkamp, Site 0096
Role: primary
Jose Vazquez-Tanus, Site 0077
Role: primary
Tomas Ripoll, Site 0109
Role: primary
Pablo García Pavia, Site 0104
Role: primary
Juan Ramon Gimeno Blanes, Site 0105
Role: primary
Rebeca Lorca Gutierrez, Site 0106
Role: primary
Ana Merino Merino, Site 0107
Role: primary
Maria Alejandra Restrepo Cordoba, Site 0108
Role: primary
José Manuel García Pinilla, Site 0103
Role: primary
Site 0113
Role: primary
Amanda Varnava, Site 0115
Role: primary
Andrew Crean, Site 0112
Role: primary
Robert Cooper, Site 0111
Role: primary
William Bradlow, Site 0110
Role: primary
Alex Simms, Site 0114
Role: primary
Zaheer Yousef, Site 0116
Role: primary
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Other Identifiers
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CV027-012
Identifier Type: -
Identifier Source: org_study_id