Actively Recruiting

Age: 18Years +
All Genders
NCT05489705

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)

Led by Bristol-Myers Squibb · Updated on 2025-11-06

1600

Participants Needed

99

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old at the time of informed consent
  • Willing and able to provide written informed consent or have a legally acceptable representative provide consent
  • United States Sub-Study: Diagnosis of obstructive HCM per 2020 AHA/ACC guidelines with LV wall thickness ≥15 mm (or ≥13 mm with family history) and LVOT gradient ≥30 mmHg at rest or provocation
  • United States Sub-Study: Documented LVEF of ≥55% by echocardiography within 6 months
  • United States Sub-Study: Symptoms consistent with NYHA functional class II-IV
  • United States Sub-Study: Receiving beta blockers, non-DHP calcium channel blockers, disopyramide, and/or mavacamten, or no treatment due to intolerance or treatment failure
  • European Sub-Study: Diagnosis of obstructive HCM consistent with recent ESC and AHA/ACC guidelines
  • European Sub-Study: Documented LVEF of ≥55% by transthoracic echocardiography
  • European Sub-Study: Symptoms consistent with NYHA functional class II-III at enrollment or within 6 months prior
  • European Sub-Study: Receiving BBs, non-DHP CCBs, disopyramide, initiating mavacamten at enrollment, or no treatment due to intolerance or failure
Not Eligible

You will not qualify if you...

  • Known phenocopy diseases such as Fabry disease or amyloidosis, or LV hypertrophy due to hypertension
  • Fixed obstruction of the outflow tract like aortic valve stenosis or valve replacement
  • Invasive septal reduction (surgical myectomy or alcohol septal ablation) within 6 months prior to enrollment
  • No prior treatment for obstructive HCM with BBs, non-DHP CCBs, or disopyramide
  • United States Sub-Study: Receiving investigational therapy for obstructive HCM other than mavacamten at enrollment
  • United States Sub-Study: Previously or currently enrolled in long-term mavacamten safety extension studies
  • European Sub-Study: Receiving investigational cardiac myosin inhibitors or modulators at enrollment
  • European Sub-Study: Previously or currently enrolled in other HCM registry studies
  • European Sub-Study: Previously or currently enrolled in mavacamten studies
  • European Sub-Study: Previously treated with mavacamten

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 99 locations

1

Alaska Heart Institute

Anchorage, Alaska, United States, 99508

Actively Recruiting

2

Pima Heart and Vascular

Tucson, Arizona, United States, 85704

Actively Recruiting

3

UAMS

Little Rock, Arkansas, United States, 72205-7199

Actively Recruiting

4

UC San Diego School of Medicine

La Jolla, California, United States, 92037

Actively Recruiting

5

Keck School of Medicine of USC-Usc

Los Angeles, California, United States, 90033

Actively Recruiting

6

Stanford Health Care Hospital & Clinics

Palo Alto, California, United States, 94304

Actively Recruiting

7

University Of California San Francisco Medical Center

San Francisco, California, United States, 94117

Actively Recruiting

8

UC Denver, AMC

Aurora, Colorado, United States, 48377

Actively Recruiting

9

Hartford HealthCare

Hartford, Connecticut, United States, 06106

Actively Recruiting

10

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

11

Uf Health Jacksonville

Jacksonville, Florida, United States, 32209

Actively Recruiting

12

University of Hawaii Cancer Center

Honolulu, Hawaii, United States, 96813

Actively Recruiting

13

University of Chicago Dept of Medicine

Chicago, Illinois, United States, 60637

Actively Recruiting

14

Indiana. University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

15

Franciscan Physician Network-Indiana Heart Physicians

Indianapolis, Indiana, United States, 46237

Actively Recruiting

16

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States, 52242

Actively Recruiting

17

University Of Kansas Medical Center & Medical Pavilion

Kansas City, Kansas, United States, 66160

Actively Recruiting

18

University Of Maryland, Ihv

Baltimore, Maryland, United States, 21201

Actively Recruiting

19

MedStar Health Research Institute

Baltimore, Maryland, United States, 21218

Actively Recruiting

20

Harvard (Massachusetts General Hospital)

Boston, Massachusetts, United States, 02114

Actively Recruiting

21

Harvard Medical School - Brigham and Women's Hospital (BWH)

Boston, Massachusetts, United States, 02215

Actively Recruiting

22

Spectrum Health Medical Group

Grand Rapids, Michigan, United States, 49525

Actively Recruiting

23

Henry Ford Health System

West Bloomfield, Michigan, United States, 48322

Actively Recruiting

24

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

25

Cardiology Associates Research, Llc

Tupelo, Mississippi, United States, 38801

Actively Recruiting

26

St. Luke's Mid-America Heart Institute

Kansas City, Missouri, United States, 64111

Actively Recruiting

27

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

28

CHI Health Reseach Center

Omaha, Nebraska, United States, 68124

Actively Recruiting

29

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

30

Morristown Medical Center

Morristown, New Jersey, United States, 07960

Actively Recruiting

31

Bassett Medical Center

Cooperstown, New York, United States, 13326

Actively Recruiting

32

Northwell Health

Manhasset, New York, United States, 11030

Actively Recruiting

33

Mount Sinai West

New York, New York, United States, 10019

Actively Recruiting

34

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

35

Saint Francis Hospital

Roslyn, New York, United States, 11576

Actively Recruiting

36

WMCHealth Advanced Physician Services

Valhalla, New York, United States, 10595

Actively Recruiting

37

Focus Clinical Research

Charlotte, North Carolina, United States, 28207

Actively Recruiting

38

Duke University Health System

Durham, North Carolina, United States, 27710

Actively Recruiting

39

Christ Hospital Health Network

Cincinnati, Ohio, United States, 45219

Actively Recruiting

40

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

41

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

42

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States, 18015

Actively Recruiting

43

Lancaster General Hospital

Lancaster, Pennsylvania, United States, 17603

Actively Recruiting

44

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

45

University Of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

46

Geisinger Health System

Wilkes-Barre, Pennsylvania, United States, 18711

Actively Recruiting

47

Prisma Health - Upstate

Greenville, South Carolina, United States, 29605

Actively Recruiting

48

Tristar Centennial Medical Ctr

Nashville, Tennessee, United States, 37203

Actively Recruiting

49

Saint Thomas Health

Nashville, Tennessee, United States, 37205-2018

Actively Recruiting

50

North Texas Cardiology Center

Dallas, Texas, United States, 75208

Actively Recruiting

51

Baylor Scott & White Research Institute

Dallas, Texas, United States, 75246

Actively Recruiting

52

The Methodist Hospital, Methodist Cancer Cencer

Houston, Texas, United States, 77030

Actively Recruiting

53

BI Research Center

Houston, Texas, United States, 77084

Actively Recruiting

54

Baylor Scott & White The Heart Hospital Plano

Plano, Texas, United States, 75093

Actively Recruiting

55

Baylor Scott & White Medical Centre - Temple

Temple, Texas, United States, 76508

Actively Recruiting

56

The Rector and Visitors of the Univ of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

57

VCU Medical Center

Richmond, Virginia, United States, 23298

Actively Recruiting

58

Carilion Clinic; Virginia Tech-Carilion School of Medicine

Roanoke, Virginia, United States, 24014

Actively Recruiting

59

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Actively Recruiting

60

WVU Hospitals

Morgantown, West Virginia, United States, 26506

Actively Recruiting

61

University Of Wisconsin - Madison

Madison, Wisconsin, United States, 53792

Actively Recruiting

62

Medical College of Wisconsin, Inc (PI Address)

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

63

KH St.Josef Braunau am Inn

Braunau am Inn, Austria, 5280

Actively Recruiting

64

LKH-Univ. Klinikum Graz

Graz, Austria, 8036

Actively Recruiting

65

Local Institution - 0088

Innsbruck, Austria, 6020

Not Yet Recruiting

66

Local Institution - 0084

Klagenfurt, Austria, 9020

Withdrawn

67

Kepler Universitätsklinikum Linz

Linz, Austria, 4021

Actively Recruiting

68

Local Institution - 0085

Sankt Pölten, Austria, 3100

Not Yet Recruiting

69

Local Institution - 0083

Vienna, Austria, 1090

Not Yet Recruiting

70

Centre Hospitalier Haguenau

Haguenau, Bas Rhin, France, 67500

Actively Recruiting

71

CHU Nantes Hopital Nord Laennec

Saint-Herblain, Loire Atlantique, France, 44800

Actively Recruiting

72

Hôpital Saint Vincent-de-Paul

Lille, Nord, France, 59000

Actively Recruiting

73

CHU Amiens-Picardie

Amiens, Somme, France, 80054

Actively Recruiting

74

Hôpital Sainte Musse

Toulon, Var, France, 83000

Actively Recruiting

75

CHU De Poitiers - Hopital De La Miletrie

Poitiers, Vienne, France, 86000

Actively Recruiting

76

Local Institution - 0117

Montpellier, France, 34000

Withdrawn

77

Ostalb-Klinikum Aalen

Aalen, Baden-Wurttemberg, Germany, 73430

Actively Recruiting

78

Local Institution - 0101

Erlangen, Bavaria, Germany, 91054

Withdrawn

79

Universitatsklinikum Muenster

Münster, North Rhine-Westphalia, Germany, 48149

Actively Recruiting

80

Praxisklinik Herz Und Gefasse-Klinikum Weisser Hirsch

Dresden, Saxony, Germany, 01099

Actively Recruiting

81

Universitaetsklinikum Leipzig Aoer

Leipzig, Saxony, Germany, 04103

Actively Recruiting

82

Immanuel Klinikum Bernau

Bernau, State of Berlin, Germany, 16321

Actively Recruiting

83

Kardiologische und angiologische Praxen im Spreebogen

Berlin, Germany, 10719

Actively Recruiting

84

Research & Cardiovascular Corp

Ponce, Puerto Rico, 00717-1322

Actively Recruiting

85

Hospital Fundacion Son Llatzer

Palma de Mallorca, Balearic Islands, Spain, 07198

Actively Recruiting

86

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain, 28222

Actively Recruiting

87

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, Spain, 30120

Actively Recruiting

88

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain, 33011

Actively Recruiting

89

Hospital Universitario de Burgos

Burgos, Spain, 09006

Actively Recruiting

90

Local Institution - 0102

Madrid, Spain, 28007

Withdrawn

91

Hospital Clinico San Carlos

Madrid, Spain, 28040

Actively Recruiting

92

Hospital Clinico Universitario Virgen de La Victoria

Málaga, Spain, 29010

Actively Recruiting

93

Local Institution - 0113

London, Greater London, United Kingdom, SW3 6NP

Not Yet Recruiting

94

Imperial College Healthcare NHS Trust

London, Greater London, United Kingdom, W6 8RF

Actively Recruiting

95

University Of Manchester

Manchester, Greater Manchester, United Kingdom, M13 9WL

Actively Recruiting

96

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, United Kingdom, L14 3PE

Actively Recruiting

97

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom, B15 2GW

Actively Recruiting

98

Leeds General Infirmary

Leeds, West Yorkshire, United Kingdom, LS1 3EX

Actively Recruiting

99

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Actively Recruiting

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Research Team

B

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

F

First line of the email MUST contain the NCT# and Site #.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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