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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Mavacamten: As per product label
Non-mavacamten symptomatic oHCM therapy: Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label
Study 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
Primary outcome measure(s)
- Incidence rate of new or worsening heart failure due to systolic dysfunction among participants with symptomatic obstructive HCM during periods of exposure to mavacamten and other oHCM treatment — Up to 5 Years
Systolic dysfunction defined as symptomatic Left Ventricular Ejection Fraction (LVEF) \< 50%. United States participants only. - Change in resting left ventricular outflow tract (LVOT) gradient from baseline — Up to 18 months
European Participants only
Trial sites (101)
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Heart Institute | Anchorage | Alaska | Recruiting |
| Pima Heart and Vascular | Tucson | Arizona | Recruiting |
| UAMS | Little Rock | Arkansas | Recruiting |
| Local Institution - 0037 | La Jolla | California | Active Not Recruiting |
| Keck School of Medicine of USC-Usc | Los Angeles | California | Recruiting |
| Stanford Health Care Hospital & Clinics | Palo Alto | California | Recruiting |
| University Of California San Francisco Medical Center | San Francisco | California | Recruiting |
| UC Denver, AMC | Aurora | Colorado | Recruiting |
| Local Institution - 0067 | Hartford | Connecticut | Active Not Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| Local Institution - 0065 | Jacksonville | Florida | Active Not Recruiting |
| Local Institution - 0046 | Honolulu | Hawaii | Active Not Recruiting |
| University of Chicago Dept of Medicine | Chicago | Illinois | Recruiting |
| Indiana. University | Indianapolis | Indiana | Recruiting |
| Franciscan Physician Network-Indiana Heart Physicians | Indianapolis | Indiana | Recruiting |
| Local Institution - 0045 | Iowa City | Iowa | Active Not Recruiting |
| Local Institution - 0059 | Baltimore | Maryland | Active Not Recruiting |
| MedStar Health Research Institute | Baltimore | Maryland | Recruiting |
| Harvard (Massachusetts General Hospital) | Boston | Massachusetts | Recruiting |
| Harvard Medical School - Brigham and Women's Hospital (BWH) | Boston | Massachusetts | Recruiting |
| Spectrum Health Medical Group | Grand Rapids | Michigan | Recruiting |
| Henry Ford Health System | West Bloomfield | Michigan | Recruiting |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | Recruiting |
| Cardiology Associates Research, Llc | Tupelo | Mississippi | Recruiting |
| St. Luke's Mid-America Heart Institute | Kansas City | Missouri | Recruiting |
| Local Institution - 0033 | Kansas City | Missouri | Active Not Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| CHI Health Reseach Center | Omaha | Nebraska | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Local Institution - 0026 | Morristown | New Jersey | Active Not Recruiting |
| Bassett Medical Center | Cooperstown | New York | Recruiting |
| Local Institution - 0009 | New York | New York | Active Not Recruiting |
| Mount Sinai Hospital | New York | New York | Recruiting |
| Saint Francis Hospital | Roslyn | New York | Recruiting |
| WMCHealth Advanced Physician Services | Valhalla | New York | Recruiting |
| Focus Clinical Research | Charlotte | North Carolina | Recruiting |
| Duke University Health System | Durham | North Carolina | Recruiting |
| Christ Hospital Health Network | Cincinnati | Ohio | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Local Institution - 0003 | Cleveland | Ohio | Active Not Recruiting |
+ 61 more sites — see the full list on the official registry below.
More Bristol-Myers Squibb trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05489705 on ClinicalTrials.gov ↗ ← All trials in Spain