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RECRUITING

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)

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1600

Start Date

2022-08-16

Completion Date

2029-08-17

Last Updated

2025-11-06

Healthy Volunteers

Conditions

Obstructive Hypertrophic Cardiomyopathy

Interventions

DRUG

Mavacamten

As per product label

DRUG

Non-mavacamten symptomatic oHCM therapy

Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label

Inclusion Criteria * ≥ 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). Exclusion Criteria * Known phenocopy disease (e.g., Fabry disease, amyloidosis) or LV hypertrophy associated with hypertension. * Documentation of any fixed obstruction of the outflow tract such as aortic valve stenosis or replacement. * Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to enrollment; participants with an unsuccessful myectomy or percutaneous ASA performed \> 6 months prior to enrollment may be enrolled. * Naïve to treatment for obstructive HCM (ie, never treated with BBs, nonDHP CCBs, or disopyramide). United States Sub-Study * Receiving an investigational therapeutic agent for obstructive HCM (eg, myosin-inhibitors other than mavacamten) in an interventional clinical trial at participant enrollment. * Previously or currently enrolled in a long-term safety extension study of mavacamten (eg, EXPLORER-HCM \[ClinicalTrials.gov, NCT03470545\], MAVA-LTE \[NCT03723655\], PIONEER-OLE \[NCT03496168\], VALORHCM \[NCT04349072\], or MAVERICK \[NCT03442764\]) European Sub-study * Receiving an investigational therapeutic agent or any cardiac myosin inhibitor and/or modulators for obstructive HCM at patient enrolment * Previously or currently enrolled in other HCM registry studies (e.g., TORCH, REMY, EU-PASS) * Previously or currently enrolled in a study of mavacamten (e.g., EXPLORER-HCM \[ClinicalTrials.gov, NCT03470545\], MAVA-LTE \[NCT03723655\], PIONEER-OLE \[NCT03496168\], VALOR-HCM \[NCT04349072\], MAVERICK \[NCT03442764\], or MEMENTO \[NCT2264899\]) * Previously treated with mavacamten

Locations (99)

Alaska Heart Institute

Anchorage, Alaska, United States

Pima Heart and Vascular

Tucson, Arizona, United States

UAMS

Little Rock, Arkansas, United States

UC San Diego School of Medicine

La Jolla, California, United States

Keck School of Medicine of USC-Usc

Los Angeles, California, United States

Stanford Health Care Hospital & Clinics

Palo Alto, California, United States

University Of California San Francisco Medical Center

San Francisco, California, United States

UC Denver, AMC

Aurora, Colorado, United States

Hartford HealthCare

Hartford, Connecticut, United States

MedStar Washington Hospital Center

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

Uf Health Jacksonville

Jacksonville, Florida, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

University of Chicago Dept of Medicine

Chicago, Illinois, United States

Indiana. University

Indianapolis, Indiana, United States

Franciscan Physician Network-Indiana Heart Physicians

Indianapolis, Indiana, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

University Of Kansas Medical Center & Medical Pavilion

Kansas City, Kansas, United States

University Of Maryland, Ihv

Baltimore, Maryland, United States

MedStar Health Research Institute

Baltimore, Maryland, United States

Harvard (Massachusetts General Hospital)

Boston, Massachusetts, United States

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

Boston, Massachusetts, United States

Spectrum Health Medical Group

Grand Rapids, Michigan, United States

Henry Ford Health System

West Bloomfield, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Cardiology Associates Research, Llc

Tupelo, Mississippi, United States

St. Luke's Mid-America Heart Institute

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

CHI Health Reseach Center

Omaha, Nebraska, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Bassett Medical Center

Cooperstown, New York, United States

Northwell Health

Manhasset, New York, United States

Mount Sinai West

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Saint Francis Hospital

Roslyn, New York, United States

WMCHealth Advanced Physician Services

Valhalla, New York, United States

Focus Clinical Research

Charlotte, North Carolina, United States

Duke University Health System

Durham, North Carolina, United States

Christ Hospital Health Network

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University Of Pittsburgh

Pittsburgh, Pennsylvania, United States

Geisinger Health System

Wilkes-Barre, Pennsylvania, United States

Prisma Health - Upstate

Greenville, South Carolina, United States

Tristar Centennial Medical Ctr

Nashville, Tennessee, United States

Saint Thomas Health

Nashville, Tennessee, United States

North Texas Cardiology Center

Dallas, Texas, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

The Methodist Hospital, Methodist Cancer Cencer

Houston, Texas, United States

BI Research Center

Houston, Texas, United States

Baylor Scott & White The Heart Hospital Plano

Plano, Texas, United States

Baylor Scott & White Medical Centre - Temple

Temple, Texas, United States

The Rector and Visitors of the Univ of Virginia

Charlottesville, Virginia, United States

VCU Medical Center

Richmond, Virginia, United States

Carilion Clinic; Virginia Tech-Carilion School of Medicine

Roanoke, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

WVU Hospitals

Morgantown, West Virginia, United States

University Of Wisconsin - Madison

Madison, Wisconsin, United States

Medical College of Wisconsin, Inc (PI Address)

Milwaukee, Wisconsin, United States

KH St.Josef Braunau am Inn

Braunau am Inn, Austria

LKH-Univ. Klinikum Graz

Graz, Austria

Local Institution - 0088

Innsbruck, Austria

Local Institution - 0084

Klagenfurt, Austria

Kepler Universitätsklinikum Linz

Linz, Austria

Local Institution - 0085

Sankt Pölten, Austria

Local Institution - 0083

Vienna, Austria

Centre Hospitalier Haguenau

Haguenau, Bas Rhin, France

CHU Nantes Hopital Nord Laennec

Saint-Herblain, Loire Atlantique, France

Hôpital Saint Vincent-de-Paul

Lille, Nord, France

CHU Amiens-Picardie

Amiens, Somme, France

Hôpital Sainte Musse

Toulon, Var, France

CHU De Poitiers - Hopital De La Miletrie

Poitiers, Vienne, France

Local Institution - 0117

Montpellier, France

Ostalb-Klinikum Aalen

Aalen, Baden-Wurttemberg, Germany

Local Institution - 0101

Erlangen, Bavaria, Germany

Universitatsklinikum Muenster

Münster, North Rhine-Westphalia, Germany

Praxisklinik Herz Und Gefasse-Klinikum Weisser Hirsch

Dresden, Saxony, Germany

Universitaetsklinikum Leipzig Aoer

Leipzig, Saxony, Germany

Immanuel Klinikum Bernau

Bernau, State of Berlin, Germany

Kardiologische und angiologische Praxen im Spreebogen

Berlin, Germany

Research & Cardiovascular Corp

Ponce, Puerto Rico

Hospital Fundacion Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario de Burgos

Burgos, Spain

Local Institution - 0102

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Clinico Universitario Virgen de La Victoria

Málaga, Spain

Local Institution - 0113

London, Greater London, United Kingdom

Imperial College Healthcare NHS Trust

London, Greater London, United Kingdom

University Of Manchester

Manchester, Greater Manchester, United Kingdom

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Leeds General Infirmary

Leeds, West Yorkshire, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom