RECRUITING

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)

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Conditions

Obstructive Hypertrophic CardiomyopathyObstructive HCM (oHCM)MavacamtenHeart failureoHCM

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-16
Study Completion:2029-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05489705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Alaska Heart Institute
Anchorage, Alaska, 99508
United States
Pima Heart and Vascular
Tucson, Arizona, 85704
United States
UAMS
Little Rock, Arkansas, 72205-7199
United States
UC San Diego School of Medicine
La Jolla, California, 92037
United States
Keck School of Medicine of USC-Usc
Los Angeles, California, 90033
United States
Stanford Health Care Hospital & Clinics
Palo Alto, California, 94304
United States
University Of California San Francisco Medical Center
San Francisco, California, 94117
United States
UC Denver, AMC
Aurora, Colorado, 48377
United States
Hartford HealthCare
Hartford, Connecticut, 06106
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Uf Health Jacksonville
Jacksonville, Florida, 32209
United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States
University of Chicago Dept of Medicine
Chicago, Illinois, 60637
United States
Indiana. University
Indianapolis, Indiana, 46202
United States
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis, Indiana, 46237
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
University Of Kansas Medical Center & Medical Pavilion
Kansas City, Kansas, 66160
United States
University Of Maryland, Ihv
Baltimore, Maryland, 21201
United States
MedStar Health Research Institute
Baltimore, Maryland, 21218
United States
Harvard (Massachusetts General Hospital)
Boston, Massachusetts, 02114
United States
Harvard Medical School - Brigham and Women's Hospital (BWH)
Boston, Massachusetts, 02215
United States
Spectrum Health Medical Group
Grand Rapids, Michigan, 49525
United States
Henry Ford Health System
West Bloomfield, Michigan, 48322
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
Cardiology Associates Research, Llc
Tupelo, Mississippi, 38801
United States
St. Luke's Mid-America Heart Institute
Kansas City, Missouri, 64111
United States
Washington University
Saint Louis, Missouri, 63110
United States
CHI Health Reseach Center
Omaha, Nebraska, 68124
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Bassett Medical Center
Cooperstown, New York, 13326
United States
Northwell Health
Manhasset, New York, 11030
United States
Mount Sinai West
New York, New York, 10019
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Saint Francis Hospital
Roslyn, New York, 11576
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
Focus Clinical Research
Charlotte, North Carolina, 28207
United States
Duke University Health System
Durham, North Carolina, 27710
United States
Christ Hospital Health Network
Cincinnati, Ohio, 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17603
United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Geisinger Health System
Wilkes-Barre, Pennsylvania, 18711
United States
Prisma Health - Upstate
Greenville, South Carolina, 29605
United States
Tristar Centennial Medical Ctr
Nashville, Tennessee, 37203
United States
Saint Thomas Health
Nashville, Tennessee, 37205-2018
United States
North Texas Cardiology Center
Dallas, Texas, 75208
United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246
United States
The Methodist Hospital, Methodist Cancer Cencer
Houston, Texas, 77030
United States
BI Research Center
Houston, Texas, 77084
United States
Baylor Scott & White The Heart Hospital Plano
Plano, Texas, 75093
United States
Baylor Scott & White Medical Centre - Temple
Temple, Texas, 76508
United States
The Rector and Visitors of the Univ of Virginia
Charlottesville, Virginia, 22908
United States
VCU Medical Center
Richmond, Virginia, 23298
United States
Carilion Clinic; Virginia Tech-Carilion School of Medicine
Roanoke, Virginia, 24014
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
WVU Hospitals
Morgantown, West Virginia, 26506
United States
University Of Wisconsin - Madison
Madison, Wisconsin, 53792
United States
Medical College of Wisconsin, Inc (PI Address)
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-16
Study Completion Date2029-08-15

Study Record Updates

Study Start Date2022-08-16
Study Completion Date2029-08-15

Terms related to this study

Keywords Provided by Researchers

  • Obstructive hypertrophic cardiomyopathy
  • Obstructive HCM (oHCM)
  • Mavacamten
  • Heart failure
  • oHCM

Additional Relevant MeSH Terms

  • Obstructive Hypertrophic Cardiomyopathy