Actively Recruiting
Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States and European Prospective Registry Study
Led by Bristol-Myers Squibb · Updated on 2025-11-06
1600
Participants Needed
99
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating real-world patient characteristics, treatment methods, and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in the United States and Europe. The study includes patients receiving mavacamten, other treatments, or no treatment due to intolerance or treatment failure. The US sub-study focuses on safety of mavacamten, while the European sub-study assesses both safety and effectiveness of mavacamten in everyday care. Participants may receive mavacamten or standard treatments like beta blockers, non-dihydropyridine calcium channel blockers, or disopyramide as prescribed by their doctors. The study observes these groups over time in routine clinical settings without altering their care. The study includes two main groups based on treatment type and monitors outcomes up to five years. Participants undergo evaluations including echocardiograms, heart function assessments using New York Heart Association (NYHA) class, left ventricular outflow tract gradient measurements, and patient-reported health questionnaires. Researchers also track heart failure events, arrhythmias, major cardiovascular events, hospitalizations, mortality, and biomarkers like NT-proBNP and cardiac troponin. Follow-up varies by region, lasting up to 18 months in Europe and up to 5 years in the United States.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of informed consent
- Willing and able to provide written informed consent or have consent provided by a legal representative
- Diagnosis of obstructive hypertrophic cardiomyopathy (HCM) per 2020 AHA/ACC guidelines (US) or current ESC/AHA/ACC guidelines (Europe)
- Left ventricular ejection fraction (LVEF) of 55% or higher recorded by echocardiography within the last 6 months
- Symptoms consistent with New York Heart Association (NYHA) functional class II-IV (US) or II-III (Europe)
- Receiving beta blockers, non-dihydropyridine calcium channel blockers, disopyramide, mavacamten, or no treatment due to intolerance or failure of prior treatments as part of routine care
You will not qualify if you...
- Known diseases mimicking HCM such as Fabry disease or amyloidosis, or left ventricular hypertrophy caused by hypertension
- Fixed obstruction of the heart's outflow tract like aortic valve stenosis or valve replacement
- Invasive septal reduction treatment (surgical myectomy or alcohol septal ablation) within 6 months before enrollment
- Never treated with beta blockers, non-dihydropyridine calcium channel blockers, or disopyramide
- Participation in other investigational treatments or certain mavacamten studies (US)
- Participation in investigational treatments or other HCM registry or mavacamten studies (Europe)
- Previous treatment with mavacamten (Europe)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants who undergo routine care for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) are observed to assess real-world patient characteristics, treatment patterns, and outcomes with mavacamten or other standard treatments.
Visits occur at baseline and periodically up to 5 years depending on participant location and treatment
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
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
F
First line of the email MUST contain the NCT# and Site #.
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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