Hypertrophic Cardiomyopathy Clinical Trial

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)

Summary

The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) treated in the real-world setting. The registry study also provide a real-world understanding of the current obstructive HCM patient population, treatment patterns, and clinical relevant outcomes for patients with symptomatic obstructive HCM in the US.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Willing and able to provide written informed consent form (ICF) and any required privacy authorization prior to the initiation of study procedures. i. Diagnosis of obstructive HCM consistent with 2020 American Heart Association/American College of Cardiology (AHA/ACC) guidelines. ii. 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.
≥ 18 years of age at the time of informed consent.
Receiving BBs, non-dihydropyridine calcium. channel blockers (non-DHP 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.

Exclusion Criteria:

Known phenocopy disease (eg, 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, non-DHP CCBs, or disopyramide).
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])

Study is for people with:

Hypertrophic Cardiomyopathy

Estimated Enrollment:

1500

Study ID:

NCT05489705

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 63 Locations for this study

See Locations Near You

Alaska Heart Institute
Anchorage Alaska, 99508, United States More Info
Ahmed Abuzaid, Site 0023
Contact
907-561-3211
Pima Heart and Vascular
Tucson Arizona, 85704, United States More Info
Greg Koshkarian, Site 0025
Contact
000-000-0000
UAMS
Little Rock Arkansas, 72205, United States More Info
Srikanth Vallurupalli, Site 0007
Contact
501-686-5545
UC San Diego School of Medicine
La Jolla California, 92037, United States More Info
Jorge Silva Enciso, Site 0037
Contact
858-246-2969
Keck School of Medicine of USC-Usc
Los Angeles California, 90033, United States More Info
Eugene DePasquale, Site 0057
Contact
323-442-6130
Stanford Health Care Hospital & Clinics
Palo Alto California, 94304, United States More Info
Matthew Wheeler, Site 0012
Contact
University Of California San Francisco Medical Center
San Francisco California, 94117, United States More Info
Theodore Abraham, Site 0021
Contact
UC Denver, AMC
Aurora Colorado, 48377, United States More Info
David Raymer, Site 0050
Contact
720-848-5300
Hartford HealthCare
Hartford Connecticut, 06106, United States More Info
Adaya Weissler-Snir, Site 0067
Contact
860-972-1506
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States More Info
Patrick Bering, Site 0081
Contact
202-877-5975
Uf Health Jacksonville
Jacksonville Florida, 32209, United States More Info
Andres Pineda, Site 0065
Contact
904-244-5371
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States More Info
Dipanjan Banerjee, Site 0046
Contact
650-533-2433
University of Chicago Dept of Medicine
Chicago Illinois, 60637, United States More Info
Gene Kim, Site 0063
Contact
773-702-9396
Indiana. University
Indianapolis Indiana, 46202, United States More Info
Roopa Rao, Site 0013
Contact
317-962-9700
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis Indiana, 46237, United States More Info
George Lolay, Site 0016
Contact
317-893-1712
University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States More Info
Ernesto Ruiz Duque, Site 0045
Contact
319-353-5245
University Of Kansas Medical Center & Medical Pavilion
Kansas City Kansas, 66160, United States More Info
Loren Berenbom, Site 0033
Contact
+910771569
University Of Maryland, Ihv
Baltimore Maryland, 21201, United States More Info
Manjula Ananthram, Site 0059
Contact
402-559-9800
MedStar Health Research Institute
Baltimore Maryland, 21218, United States More Info
Sandeep Jani, Site 0030
Contact
44327891702
Harvard (Massachusetts General Hospital)
Boston Massachusetts, 02114, United States More Info
Albree Tower-Rader, Site 0024
Contact
617-724-5434
Harvard Medical School - Brigham and Women's Hospital (BWH)
Boston Massachusetts, 02215, United States More Info
Carolyn Ho, Site 0068
Contact
617-732-5500
Spectrum Health Medical Group
Grand Rapids Michigan, 49525, United States More Info
David Fermin, Site 0073
Contact
616-885-5000
Henry Ford Health System
West Bloomfield Michigan, 48322, United States More Info
Karthikeyan Ananthasubramaniam, Site 0034
Contact
Minneapolis Heart Institute Foundation
Minneapolis Minnesota, 55407, United States More Info
Robert Fraser, Site 0010
Contact
612-863-3900
Cardiology Associates Research, Llc
Tupelo Mississippi, 38801, United States More Info
Barry Bertolet, Site 0062
Contact
904-392-2469
St. Luke's Mid-America Heart Institute
Kansas City Missouri, 64111, United States More Info
Michael Nassif, Site 0069
Contact
Washington University
Saint Louis Missouri, 63110, United States More Info
Richard Bach, Site 0036
Contact
314-362-1963
CHI Health Reseach Center
Omaha Nebraska, 68124, United States More Info
Amjad Kabach, Site 0070
Contact
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Dmitry Nemirovsky, Site 0029
Contact
551-996-5870
Morristown Medical Center
Morristown New Jersey, 07960, United States More Info
Matthew Martinez, Site 0026
Contact
973-971-5194
Bassett Medical Center
Cooperstown New York, 13326, United States More Info
Mun Hong, Site 0006
Contact
607-547-4582
Northwell Health
Manhasset New York, 11030, United States More Info
Ronald Wharton, Site 0001
Contact
516-562-3317
Mount Sinai West
New York New York, 10019, United States More Info
Kim Kim, Site 0009
Contact
212-492-5550
Mount Sinai Hospital
New York New York, 10029, United States More Info
Johanna Contreras, Site 0035
Contact
917-751-5850
Saint Francis Hospital
Roslyn New York, 11576, United States More Info
Allen Jeremias, Site 0075
Contact
631-707-2586
Westchester Medical Center
Valhalla New York, 10595, United States More Info
Srihari Naidu, Site 0053
Contact
914-493-7760
Focus Clinical Research
Charlotte North Carolina, 28207, United States More Info
Aamer Qurehshi, Site 0040
Contact
888-635-0552
Duke University Health System
Durham North Carolina, 27710, United States More Info
Andrew Wang, Site 0022
Contact
Christ Hospital Health Network
Cincinnati Ohio, 45219, United States More Info
Wojciech Mazur, Site 0015
Contact
513-721-8881
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Anene Clair Ukaigwe, Site 0041
Contact
216-286-1023
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Milind Desai, Site 0003
Contact
216-445-5250
St. Luke's University Health Network
Bethlehem Pennsylvania, 18015, United States More Info
Jamshid Shirani, Site 0043
Contact
718-430-3314
Lancaster General Hospital
Lancaster Pennsylvania, 17603, United States More Info
Robert Donovan, Site 0076
Contact
412-613-7238
AHN Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States More Info
Craig Alpert, Site 0002
Contact
412-359-6739
University Of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States More Info
Timothy Wong, Site 0027
Contact
Geisinger Health System
Wilkes-Barre Pennsylvania, 18711, United States More Info
Vernon Mascarenhas, Site 0056
Contact
570-808-6020
Prisma Health - Upstate
Greenville South Carolina, 29605, United States More Info
Josh Doll, Site 0042
Contact
864-455-7727
Tristar Centennial Medical Ctr
Nashville Tennessee, 37203, United States More Info
Bryan Doherty, Site 0048
Contact
347-949-3060
Saint Thomas Health
Nashville Tennessee, 37205, United States More Info
Mark Zenker, Site 0019
Contact
615-269-4545
North Texas Cardiology Center
Dallas Texas, 75208, United States More Info
Manavjot Sidhu, Site 0018
Contact
214-933-7430
Baylor Scott & White Research Institute
Dallas Texas, 75246, United States More Info
Robert Gottlieb, Site 0008
Contact
The Methodist Hospital, Methodist Cancer Cencer
Houston Texas, 77030, United States More Info
Sherif Nagueh, Site 0058
Contact
713-441-2850
BI Research Center
Houston Texas, 77084, United States More Info
Asif Akhtar, Site 0039
Contact
281-944-3610
Baylor Scott & White The Heart Hospital Plano
Plano Texas, 75093, United States More Info
David Rawitscher, Site 0028
Contact
469-800-6390
Baylor Scott & White Medical Centre - Temple
Temple Texas, 76508, United States More Info
Vinh Nguyen, Site 0051
Contact
254-724-5119
The Rector and Visitors of the Univ of Virginia
Charlottesville Virginia, 22908, United States More Info
Christopher Kramer, Site 0011
Contact
434-982-0853
VCU Medical Center
Richmond Virginia, 23298, United States More Info
Mohammed Makkiya, Site 0080
Contact
804-828-9989
Carilion Clinic; Virginia Tech-Carilion School of Medicine
Roanoke Virginia, 24014, United States More Info
Ali Hama Amin, Site 0044
Contact
540-982-8204
Virginia Mason Medical Center
Seattle Washington, 98101, United States More Info
Mariko Harper, Site 0052
Contact
206-341-1111
WVU Hospitals
Morgantown West Virginia, 26506, United States More Info
Christopher Bianco, Site 0055
Contact
304-598-4000
University Of Wisconsin - Madison
Madison Wisconsin, 53792, United States More Info
Ravi Dhingra, Site 0004
Contact
608-265-1918
Medical College of Wisconsin, Inc (PI Address)
Milwaukee Wisconsin, 53226, United States More Info
Abhinav Sharma, Site 0054
Contact
414-805-6000
Research & Cardiovascular Corp
Ponce , 00717, Puerto Rico More Info
Jose Vazquez-Tanus, Site 0077
Contact
7872908585

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Estimated Enrollment:

1500

Study ID:

NCT05489705

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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