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NCT05489705Recruiting

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)

Bristol-Myers Squibb

Start Date

8/16/2022

Completion Date

8/17/2029

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Mavacamten

DRUG

Non-mavacamten symptomatic oHCM therapy

Interested in This Trial?

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Conditions

Obstructive Hypertrophic Cardiomyopathy

Locations

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 D.C., 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

St 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

WMCHealth Advanced Physician Services

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

KH St.Josef Braunau am Inn

Braunau am Inn, 5280

Austria

LKH-Univ. Klinikum Graz

Graz, 8036

Austria

Local Institution - 0088

Innsbruck, 6020

Austria

Local Institution - 0084

Klagenfurt, 9020

Austria

Kepler Universitätsklinikum Linz

Linz, 4021

Austria

Local Institution - 0085

Sankt Pölten, 3100

Austria

Local Institution - 0083

Vienna, 1090

Austria

Centre Hospitalier Haguenau

Haguenau, Bas Rhin 67500

France

CHU Nantes Hopital Nord Laennec

Saint-Herblain, Loire Atlantique 44800

France

Hôpital Saint Vincent-de-Paul

Lille, Nord 59000

France

CHU Amiens-Picardie

Amiens, Somme 80054

France

Hôpital Sainte Musse

Toulon, Var 83000

France

CHU De Poitiers - Hopital De La Miletrie

Poitiers, Vienne 86000

France

Local Institution - 0117

Montpellier, 34000

France

Ostalb-Klinikum Aalen

Aalen, Baden-Wurttemberg 73430

Germany

Local Institution - 0101

Erlangen, Bavaria 91054

Germany

Universitatsklinikum Muenster

Münster, North Rhine-Westphalia 48149

Germany

Praxisklinik Herz Und Gefasse-Klinikum Weisser Hirsch

Dresden, Saxony 01099

Germany

Universitaetsklinikum Leipzig Aoer

Leipzig, Saxony 04103

Germany

Immanuel Klinikum Bernau

Bernau, State of Berlin 16321

Germany

Kardiologische und angiologische Praxen im Spreebogen

Berlin, 10719

Germany

Research & Cardiovascular Corp

Ponce, 00717-1322

Puerto Rico

Hospital Fundacion Son Llatzer

Palma de Mallorca, Balearic Islands 07198

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid 28222

Spain

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia 30120

Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias 33011

Spain

Hospital Universitario de Burgos

Burgos, 09006

Spain

Local Institution - 0102

Madrid, 28007

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Clinico Universitario Virgen de La Victoria

Málaga, 29010

Spain

Local Institution - 0113

London, Greater London SW3 6NP

United Kingdom

Imperial College Healthcare NHS Trust

London, Greater London W6 8RF

United Kingdom

University Of Manchester

Manchester, Greater Manchester M13 9WL

United Kingdom

Liverpool Heart and Chest Hospital

Liverpool, Merseyside L14 3PE

United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands B15 2GW

United Kingdom

Leeds General Infirmary

Leeds, West Yorkshire LS1 3EX

United Kingdom

University Hospital of Wales

Cardiff, CF14 4XW

United Kingdom