Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States and European Prospective Registry Study

Status: Recruiting
Location: See all (98) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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).

Locations
United States
Alaska
Alaska Heart Institute
RECRUITING
Anchorage
Arkansas
UAMS
RECRUITING
Little Rock
Arizona
Pima Heart and Vascular
RECRUITING
Tucson
California
UC San Diego School of Medicine
RECRUITING
La Jolla
Keck School of Medicine of USC-Usc
RECRUITING
Los Angeles
Stanford Health Care Hospital & Clinics
RECRUITING
Palo Alto
University Of California San Francisco Medical Center
RECRUITING
San Francisco
Colorado
UC Denver, AMC
RECRUITING
Aurora
Connecticut
Hartford HealthCare
RECRUITING
Hartford
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Uf Health Jacksonville
RECRUITING
Jacksonville
Hawaii
University of Hawaii Cancer Center
RECRUITING
Honolulu
Iowa
University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Illinois
University of Chicago Dept of Medicine
RECRUITING
Chicago
Indiana
Franciscan Physician Network-Indiana Heart Physicians
RECRUITING
Indianapolis
Indiana. University
RECRUITING
Indianapolis
Kansas
University Of Kansas Medical Center & Medical Pavilion
RECRUITING
Kansas City
Massachusetts
Harvard (Massachusetts General Hospital)
RECRUITING
Boston
Harvard Medical School - Brigham and Women's Hospital (BWH)
RECRUITING
Boston
Maryland
MedStar Health Research Institute
RECRUITING
Baltimore
University Of Maryland, Ihv
RECRUITING
Baltimore
Michigan
Spectrum Health Medical Group
RECRUITING
Grand Rapids
Henry Ford Health System
RECRUITING
West Bloomfield
Minnesota
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
Missouri
St. Luke's Mid-America Heart Institute
RECRUITING
Kansas City
Washington University
RECRUITING
St Louis
Mississippi
Cardiology Associates Research, Llc
RECRUITING
Tupelo
North Carolina
Focus Clinical Research
RECRUITING
Charlotte
Duke University Health System
RECRUITING
Durham
Nebraska
CHI Health Reseach Center
RECRUITING
Omaha
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Morristown Medical Center
RECRUITING
Morristown
New York
Bassett Medical Center
RECRUITING
Cooperstown
Northwell Health
RECRUITING
Manhasset
Mount Sinai Hospital
RECRUITING
New York
Mount Sinai West
RECRUITING
New York
Saint Francis Hospital
RECRUITING
Roslyn
WMCHealth Advanced Physician Services
RECRUITING
Valhalla
Ohio
Christ Hospital Health Network
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
St. Luke's University Health Network
RECRUITING
Bethlehem
Lancaster General Hospital
RECRUITING
Lancaster
AHN Allegheny General Hospital
RECRUITING
Pittsburgh
University Of Pittsburgh
RECRUITING
Pittsburgh
Geisinger Health System
RECRUITING
Wilkes-barre
South Carolina
Prisma Health - Upstate
RECRUITING
Greenville
Tennessee
Saint Thomas Health
RECRUITING
Nashville
Tristar Centennial Medical Ctr
RECRUITING
Nashville
Texas
Baylor Scott & White Research Institute
RECRUITING
Dallas
North Texas Cardiology Center
RECRUITING
Dallas
BI Research Center
RECRUITING
Houston
The Methodist Hospital, Methodist Cancer Cencer
RECRUITING
Houston
Baylor Scott & White The Heart Hospital Plano
RECRUITING
Plano
Baylor Scott & White Medical Centre - Temple
RECRUITING
Temple
Virginia
The Rector and Visitors of the Univ of Virginia
RECRUITING
Charlottesville
VCU Medical Center
RECRUITING
Richmond
Carilion Clinic; Virginia Tech-Carilion School of Medicine
RECRUITING
Roanoke
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Wisconsin
University Of Wisconsin - Madison
RECRUITING
Madison
Medical College of Wisconsin, Inc (PI Address)
RECRUITING
Milwaukee
West Virginia
WVU Hospitals
RECRUITING
Morgantown
Other Locations
Austria
Local Institution - 0082
NOT_YET_RECRUITING
Braunau Am Inn
Local Institution - 0087
NOT_YET_RECRUITING
Graz
Local Institution - 0088
NOT_YET_RECRUITING
Innsbruck
Local Institution - 0084
NOT_YET_RECRUITING
Klagenfurt
Local Institution - 0086
NOT_YET_RECRUITING
Linz
Local Institution - 0085
NOT_YET_RECRUITING
Sankt Pölten
Local Institution - 0083
NOT_YET_RECRUITING
Vienna
France
Local Institution - 0091
NOT_YET_RECRUITING
Amiens
Centre Hospitalier Haguenau
RECRUITING
Haguenau
Local Institution - 0090
NOT_YET_RECRUITING
Lille
Local Institution - 0089
NOT_YET_RECRUITING
Poitiers
Local Institution - 0093
NOT_YET_RECRUITING
Saint-herblain
Local Institution - 0094
NOT_YET_RECRUITING
Toulon
Germany
Local Institution - 0098
NOT_YET_RECRUITING
Aalen
Local Institution - 0096
NOT_YET_RECRUITING
Berlin
Local Institution - 0095
NOT_YET_RECRUITING
Bernau
Local Institution - 0099
NOT_YET_RECRUITING
Dresden
Local Institution - 0101
NOT_YET_RECRUITING
Erlangen
Local Institution - 0097
NOT_YET_RECRUITING
Leipzig
Local Institution - 0100
NOT_YET_RECRUITING
Münster
Puerto Rico
Research & Cardiovascular Corp
RECRUITING
Ponce
Spain
Local Institution - 0107
NOT_YET_RECRUITING
Burgos
Local Institution - 0105
NOT_YET_RECRUITING
El Palmar
Local Institution - 0102
NOT_YET_RECRUITING
Madrid
Local Institution - 0108
NOT_YET_RECRUITING
Madrid
Local Institution - 0104
NOT_YET_RECRUITING
Majadahonda
Local Institution - 0103
NOT_YET_RECRUITING
Málaga
Local Institution - 0106
NOT_YET_RECRUITING
Oviedo
Local Institution - 0109
NOT_YET_RECRUITING
Palma De Mallorca
United Kingdom
Local Institution - 0110
NOT_YET_RECRUITING
Birmingham
Local Institution - 0116
NOT_YET_RECRUITING
Cardiff
Local Institution - 0114
NOT_YET_RECRUITING
Leeds
Local Institution - 0111
NOT_YET_RECRUITING
Liverpool
Local Institution - 0113
NOT_YET_RECRUITING
London
Local Institution - 0115
NOT_YET_RECRUITING
London
Local Institution - 0112
NOT_YET_RECRUITING
Manchester
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2022-08-16
Estimated Completion Date: 2029-08-17
Participants
Target number of participants: 1600
Treatments
Mavacamten
Participants will receive mavacamten as prescribed by a physician according to standard of care for symptomatic oHCM
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
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov