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)

Purpose

This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment. 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.

Condition

  • Obstructive Hypertrophic Cardiomyopathy

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Mavacamten Participants will receive mavacamten as prescribed by a physician according to standard of care for symptomatic oHCM
  • Drug: 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
  • Drug: Non-mavacamten symptomatic oHCM therapy
    Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label

Recruiting Locations

Alaska Heart Institute
Anchorage, Alaska 99508
Contact:
Ahmed Abuzaid, Site 0023
907-561-3211

Pima Heart and Vascular
Tucson, Arizona 85704
Contact:
Greg Koshkarian, Site 0025
000-000-0000

UAMS
Little Rock, Arkansas 72205-7199
Contact:
Srikanth Vallurupalli, Site 0007
501-686-5545

UC San Diego School of Medicine
La Jolla, California 92037
Contact:
Jorge Silva Enciso, Site 0037
858-246-2969

Keck School of Medicine of USC-Usc
Los Angeles, California 90033
Contact:
Eugene DePasquale, Site 0057
323-442-6130

Stanford Health Care Hospital & Clinics
Palo Alto, California 94304
Contact:
Matthew Wheeler, Site 0012

University Of California San Francisco Medical Center
San Francisco, California 94117
Contact:
Theodore Abraham, Site 0021

UC Denver, AMC
Aurora, Colorado 48377
Contact:
David Raymer, Site 0050
720-848-5300

Hartford HealthCare
Hartford, Connecticut 06106
Contact:
Adaya Weissler-Snir, Site 0067
860-972-1506

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Patrick Bering, Site 0081
202-877-5975

Uf Health Jacksonville
Jacksonville, Florida 32209
Contact:
Andres Pineda, Site 0065
904-244-5371

University of Hawaii Cancer Center
Honolulu, Hawaii 96813
Contact:
Dipanjan Banerjee, Site 0046
650-533-2433

University of Chicago Dept of Medicine
Chicago, Illinois 60637
Contact:
Gene Kim, Site 0063
773-702-9396

Indiana. University
Indianapolis, Indiana 46202
Contact:
Roopa Rao, Site 0013
317-962-9700

Franciscan Physician Network-Indiana Heart Physicians
Indianapolis, Indiana 46237
Contact:
George Lolay, Site 0016
317-893-1712

University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
Contact:
Ernesto Ruiz Duque, Site 0045
319-353-5245

University Of Kansas Medical Center & Medical Pavilion
Kansas City, Kansas 66160
Contact:
Loren Berenbom, Site 0033

University Of Maryland, Ihv
Baltimore, Maryland 21201
Contact:
Manjula Ananthram, Site 0059
402-559-9800

MedStar Health Research Institute
Baltimore, Maryland 21218
Contact:
Sandeep Jani, Site 0030

Harvard (Massachusetts General Hospital)
Boston, Massachusetts 02114
Contact:
Albree Tower-Rader, Site 0024
617-724-5434

Harvard Medical School - Brigham and Women's Hospital (BWH)
Boston, Massachusetts 02215
Contact:
Carolyn Ho, Site 0068
617-732-5500

Spectrum Health Medical Group
Grand Rapids, Michigan 49525
Contact:
David Fermin, Site 0073
616-885-5000

Henry Ford Health System
West Bloomfield, Michigan 48322
Contact:
Karthikeyan Ananthasubramaniam, Site 0034

Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
Contact:
Robert Fraser, Site 0010
612-863-3900

Cardiology Associates Research, Llc
Tupelo, Mississippi 38801
Contact:
Barry Bertolet, Site 0062
904-392-2469

St. Luke's Mid-America Heart Institute
Kansas City, Missouri 64111
Contact:
Michael Nassif, Site 0069

Washington University
Saint Louis, Missouri 63110
Contact:
Richard Bach, Site 0036
314-362-1963

CHI Health Reseach Center
Omaha, Nebraska 68124
Contact:
Amjad Kabach, Site 0070

Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Dmitry Nemirovsky, Site 0029
551-996-5870

Morristown Medical Center
Morristown, New Jersey 07960
Contact:
Matthew Martinez, Site 0026
973-971-5194

Bassett Medical Center
Cooperstown, New York 13326
Contact:
Mun Hong, Site 0006
607-547-4582

Northwell Health
Manhasset, New York 11030
Contact:
Ronald Wharton, Site 0001
516-562-3317

Mount Sinai West
New York, New York 10019
Contact:
Kim Kim, Site 0009
212-492-5550

Mount Sinai Hospital
New York, New York 10029
Contact:
Johanna Contreras, Site 0035
917-751-5850

Saint Francis Hospital
Roslyn, New York 11576
Contact:
Allen Jeremias, Site 0075
631-707-2586

WMCHealth Advanced Physician Services
Valhalla, New York 10595
Contact:
Srihari Naidu, Site 0053
914-598-7651

Focus Clinical Research
Charlotte, North Carolina 28207
Contact:
Aamer Qurehshi, Site 0040
888-635-0552

Duke University Health System
Durham, North Carolina 27710
Contact:
Andrew Wang, Site 0022

Christ Hospital Health Network
Cincinnati, Ohio 45219
Contact:
Wojciech Mazur, Site 0015
513-721-8881

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Contact:
Anene Clair Ukaigwe, Site 0041
216-286-1023

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Milind Desai, Site 0003
216-445-5250

St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
Contact:
Jamshid Shirani, Site 0043
718-430-3314

Lancaster General Hospital
Lancaster, Pennsylvania 17603
Contact:
Robert Donovan, Site 0076
412-613-7238

AHN Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Contact:
Craig Alpert, Site 0002
412-359-6739

University Of Pittsburgh
Pittsburgh, Pennsylvania 15213
Contact:
Timothy Wong, Site 0027

Geisinger Health System
Wilkes-Barre, Pennsylvania 18711
Contact:
Vernon Mascarenhas, Site 0056
570-808-6020

Prisma Health - Upstate
Greenville, South Carolina 29605
Contact:
Josh Doll, Site 0042
864-455-7727

Tristar Centennial Medical Ctr
Nashville, Tennessee 37203
Contact:
Bryan Doherty, Site 0048
347-949-3060

Saint Thomas Health
Nashville, Tennessee 37205-2018
Contact:
Mark Zenker, Site 0019
615-269-4545

North Texas Cardiology Center
Dallas, Texas 75208
Contact:
Manavjot Sidhu, Site 0018
214-933-7430

Baylor Scott & White Research Institute
Dallas, Texas 75246
Contact:
Robert Gottlieb, Site 0008

The Methodist Hospital, Methodist Cancer Cencer
Houston, Texas 77030
Contact:
Sherif Nagueh, Site 0058
713-441-2850

BI Research Center
Houston, Texas 77084
Contact:
Asif Akhtar, Site 0039
281-944-3610

Baylor Scott & White The Heart Hospital Plano
Plano, Texas 75093
Contact:
David Rawitscher, Site 0028
469-800-6390

Baylor Scott & White Medical Centre - Temple
Temple, Texas 76508
Contact:
Vinh Nguyen, Site 0051
254-724-5119

The Rector and Visitors of the Univ of Virginia
Charlottesville, Virginia 22908
Contact:
Christopher Kramer, Site 0011
434-982-0853

VCU Medical Center
Richmond, Virginia 23298
Contact:
Mohammed Makkiya, Site 0080
804-828-9989

Carilion Clinic; Virginia Tech-Carilion School of Medicine
Roanoke, Virginia 24014
Contact:
Ali Hama Amin, Site 0044
540-982-8204

Virginia Mason Medical Center
Seattle, Washington 98101
Contact:
Mariko Harper, Site 0052
206-341-1111

WVU Hospitals
Morgantown, West Virginia 26506
Contact:
Christopher Bianco, Site 0055
304-598-4000

University Of Wisconsin - Madison
Madison, Wisconsin 53792
Contact:
Ravi Dhingra, Site 0004
608-265-1918

Medical College of Wisconsin, Inc (PI Address)
Milwaukee, Wisconsin 53226
Contact:
Abhinav Sharma, Site 0054
414-805-6000

Research & Cardiovascular Corp
Ponce, Puerto Rico 00717-1322
Contact:
Jose Vazquez-Tanus, Site 0077
7872908585

More Details

NCT ID
NCT05489705
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center