A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment…

Obstructive Hypertrophic CardiomyopathyDrug

RecruitingNo phase

Obstructive Hypertrophic CardiomyopathyDrug

NCT05489705

Long-term study of people taking mavacamten or other treatments for obstructive hypertrophic cardiomyopathy

Our summary — not written by the study team

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

Do you qualify?

20 criteria to check

Time: Followed for up to 5 years
When the study takes its last measurement. Ask the team for the full schedule. Study record
Pay: Estimate: $20–$75 per visit
Sponsor hasn't indicated
An estimate, not an offer. Confirm with the study team. Saturn's Estimate

80 open sites · Anchorage, Alaska · 79 more

What this study is

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.

What's being tested

Mavacamten
Intervention · DRUG
As per product label
Non-mavacamten symptomatic oHCM therapy
Intervention · DRUG
Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label

Study details

Official title: Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States and European Prospective Registry Study
Sponsor: Bristol-Myers Squibb
Conditions: Obstructive Hypertrophic Cardiomyopathy
Enrolling: 1,700 people
Starts: 2022-08-16
Est. completion: 2029-08-17
Record: View on ClinicalTrials.gov ↗

Who can join

Age 18 Years and overSex ALLHealthy volunteers Not accepted

You may qualify if

≥ 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).

You can't join if

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

Study locations (101)

80 open

Alaska Heart Institute
Anchorage, Alaska, United States
- Ahmed Abuzaid, Site 0023 · Contact907-561-3211
Recruiting
Pima Heart and Vascular
Tucson, Arizona, United States
- Greg Koshkarian, Site 0025 · Contact000-000-0000
Recruiting
UAMS
Little Rock, Arkansas, United States
- Srikanth Vallurupalli, Site 0007 · Contact501-686-5545
Recruiting
Keck School of Medicine of USC-Usc
Los Angeles, California, United States
- Eugene DePasquale, Site 0057 · Contact323-442-6130
Recruiting
Stanford Health Care Hospital & Clinics
Palo Alto, California, United States
- Matthew Wheeler, Site 0012 · Contact
Recruiting
University Of California San Francisco Medical Center
San Francisco, California, United States
- Theodore Abraham, Site 0021 · Contact
Recruiting
UC Denver, AMC
Aurora, Colorado, United States
- David Raymer, Site 0050 · Contact720-848-5300
Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
- Patrick Bering, Site 0081 · Contact202-877-5975
Recruiting
University of Chicago Dept of Medicine
Chicago, Illinois, United States
- Gene Kim, Site 0063 · Contact773-702-9396
Recruiting
Indiana. University
Indianapolis, Indiana, United States
- Roopa Rao, Site 0013 · Contact317-962-9700
Recruiting
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis, Indiana, United States
- George Lolay, Site 0016 · Contact317-893-1712
Recruiting
MedStar Health Research Institute
Baltimore, Maryland, United States
- Sandeep Jani, Site 0030 · Contact
Recruiting
Harvard (Massachusetts General Hospital)
Boston, Massachusetts, United States
- Albree Tower-Rader, Site 0024 · Contact617-724-5434
Recruiting
Harvard Medical School - Brigham and Women's Hospital (BWH)
Boston, Massachusetts, United States
- Carolyn Ho, Site 0068 · Contact617-732-5500
Recruiting
Spectrum Health Medical Group
Grand Rapids, Michigan, United States
- David Fermin, Site 0073 · Contact616-885-5000
Recruiting
Henry Ford Health System
West Bloomfield, Michigan, United States
- Karthikeyan Ananthasubramaniam, Site 0034 · Contact
Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
- Robert Fraser, Site 0010 · Contact612-863-3900
Recruiting
Cardiology Associates Research, Llc
Tupelo, Mississippi, United States
- Barry Bertolet, Site 0062 · Contact904-392-2469
Recruiting
St. Luke's Mid-America Heart Institute
Kansas City, Missouri, United States
- Michael Nassif, Site 0069 · Contact
Recruiting
Washington University
St Louis, Missouri, United States
- Richard Bach, Site 0036 · Contact314-362-1963
Recruiting
CHI Health Reseach Center
Omaha, Nebraska, United States
- Amjad Kabach, Site 0070 · Contact
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
- Dmitry Nemirovsky, Site 0029 · Contact551-996-5870
Recruiting
Bassett Medical Center
Cooperstown, New York, United States
- Mun Hong, Site 0006 · Contact607-547-4582
Recruiting
Mount Sinai Hospital
New York, New York, United States
- Johanna Contreras, Site 0035 · Contact917-751-5850
Recruiting
Saint Francis Hospital
Roslyn, New York, United States
- Allen Jeremias, Site 0075 · Contact631-707-2586
Recruiting
WMCHealth Advanced Physician Services
Valhalla, New York, United States
- Srihari Naidu, Site 0053 · Contact914-598-7651
Recruiting
Focus Clinical Research
Charlotte, North Carolina, United States
- Aamer Qurehshi, Site 0040 · Contact888-635-0552
Recruiting
Duke University Health System
Durham, North Carolina, United States
- Andrew Wang, Site 0022 · Contact
Recruiting
Christ Hospital Health Network
Cincinnati, Ohio, United States
- Wojciech Mazur, Site 0015 · Contact513-721-8881
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
- Anene Clair Ukaigwe, Site 0041 · Contact216-286-1023
Recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
- Jamshid Shirani, Site 0043 · Contact718-430-3314
Recruiting
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Timothy Wong, Site 0027 · Contact
Recruiting
Geisinger Health System
Wilkes-Barre, Pennsylvania, United States
- Vernon Mascarenhas, Site 0056 · Contact570-808-6020
Recruiting
Prisma Health - Upstate
Greenville, South Carolina, United States
- Josh Doll, Site 0042 · Contact864-455-7727
Recruiting
Tristar Centennial Medical Ctr
Nashville, Tennessee, United States
- Bryan Doherty, Site 0048 · Contact347-949-3060
Recruiting
Saint Thomas Health
Nashville, Tennessee, United States
- Mark Zenker, Site 0019 · Contact615-269-4545
Recruiting
North Texas Cardiology Center
Dallas, Texas, United States
- Manavjot Sidhu, Site 0018 · Contact214-933-7430
Recruiting
Baylor Scott & White Research Institute
Dallas, Texas, United States
- Robert Gottlieb, Site 0008 · Contact
Recruiting
The Methodist Hospital, Methodist Cancer Cencer
Houston, Texas, United States
- Sherif Nagueh, Site 0058 · Contact713-441-2850
Recruiting
BI Research Center
Houston, Texas, United States
- Asif Akhtar, Site 0039 · Contact281-944-3610
Recruiting
Baylor Scott & White The Heart Hospital Plano
Plano, Texas, United States
- David Rawitscher, Site 0028 · Contact469-800-6390
Recruiting
Baylor Scott & White Medical Centre - Temple
Temple, Texas, United States
- Vinh Nguyen, Site 0051 · Contact254-724-5119
Recruiting
The Rector and Visitors of the Univ of Virginia
Charlottesville, Virginia, United States
- Christopher Kramer, Site 0011 · Contact434-982-0853
Recruiting
VCU Medical Center
Richmond, Virginia, United States
- Mohammed Makkiya, Site 0080 · Contact804-828-9989
Recruiting
Carilion Clinic; Virginia Tech-Carilion School of Medicine
Roanoke, Virginia, United States
- Ali Hama Amin, Site 0044 · Contact540-982-8204
Recruiting
Virginia Mason Medical Center
Seattle, Washington, United States
- Mariko Harper, Site 0052 · Contact206-341-1111
Recruiting
WVU Hospitals
Morgantown, West Virginia, United States
- Christopher Bianco, Site 0055 · Contact304-598-4000
Recruiting
Medical College of Wisconsin, Inc (PI Address)
Milwaukee, Wisconsin, United States
- Abhinav Sharma, Site 0054 · Contact414-805-6000
Recruiting
Local Institution - 0037
La Jolla, California, United States
Active, not recruiting
Local Institution - 0067
Hartford, Connecticut, United States
Active, not recruiting
Local Institution - 0065
Jacksonville, Florida, United States
Active, not recruiting
Local Institution - 0046
Honolulu, Hawaii, United States
Active, not recruiting
Local Institution - 0045
Iowa City, Iowa, United States
Active, not recruiting
Local Institution - 0059
Baltimore, Maryland, United States
Active, not recruiting
Local Institution - 0033
Kansas City, Missouri, United States
Active, not recruiting
Local Institution - 0026
Morristown, New Jersey, United States
Active, not recruiting
Local Institution - 0009
New York, New York, United States
Active, not recruiting
Local Institution - 0003
Cleveland, Ohio, United States
Active, not recruiting
Local Institution - 0076
Lancaster, Pennsylvania, United States
Active, not recruiting
Local Institution - 0004
Madison, Wisconsin, United States
Active, not recruiting

41 sites outside the US

KH St.Josef Braunau am Inn
Braunau am Inn, Austria
- Johann Auer, Site 0082 · Contact+437722804510
Recruiting
LKH-Univ. Klinikum Graz
Graz, Austria
- Nicolas Verheyen, Site 0087 · Contact+433163851254
Recruiting
Local Institution - 0088
Innsbruck, Austria
- Site 0088 · Contact
Not yet recruiting
Kepler Universitätsklinikum Linz
Linz, Austria
- Christian Reiter, Site 0086 · Contact4357680836220
Recruiting
Local Institution - 0085
Sankt Pölten, Austria
- Site 0085 · Contact
Not yet recruiting
Local Institution - 0083
Vienna, Austria
- Site 0083 · Contact
Not yet recruiting
Centre Hospitalier Haguenau
Haguenau, Bas Rhin, France
- Charlotte Dagrenat, Site 0092 · Contact33388063435
Recruiting
CHU Nantes Hopital Nord Laennec
Saint-Herblain, Loire Atlantique, France
- Nicolas Piriou, Site 0093 · Contact+33240165716
Recruiting
Hôpital Saint Vincent-de-Paul
Lille, Nord, France
- Ludovic Appert, Site 0090 · Contact33320874996
Recruiting
CHU Amiens-Picardie
Amiens, Somme, France
- Yohann Bohbot, Site 0091 · Contact33322087258
Recruiting
Hôpital Sainte Musse
Toulon, Var, France
- Jean-Michel Tartière, Site 0094 · Contact33483772070
Recruiting
CHU De Poitiers - Hopital De La Miletrie
Poitiers, Vienne, France
- Benjamin Alos, Site 0089 · Contact33549444444
Recruiting
Ostalb-Klinikum Aalen
Aalen, Baden-Wurttemberg, Germany
- Stephanie Loebig, Site 0098 · Contact497361550
Recruiting
Universitatsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
- Jürgen Sindermann, Site 0100 · Contact+492518347426
Recruiting
Praxisklinik Herz Und Gefasse-Klinikum Weisser Hirsch
Dresden, Saxony, Germany
- Gregor Simonis, Site 0099 · Contact493518064440
Recruiting
Universitaetsklinikum Leipzig Aoer
Leipzig, Saxony, Germany
- Karsten Lenk, Site 0097 · Contact+4936419324521000000
Recruiting
Immanuel Klinikum Bernau
Bernau, State of Berlin, Germany
- Christian Butter, Site 0095 · Contact+493338694644
Recruiting
Kardiologische und angiologische Praxen im Spreebogen
Berlin, Germany
- Wilhelm Haverkamp, Site 0096 · Contact+4930450565906
Recruiting
Research & Cardiovascular Corp
Ponce, Puerto Rico
- Jose Vazquez-Tanus, Site 0077 · Contact7872908585
Recruiting
Hospital Fundacion Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
- Tomas Ripoll, Site 0109 · Contact+34871202102
Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
- Pablo García Pavia, Site 0104 · Contact+34911917297
Recruiting
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain
- Juan Ramon Gimeno Blanes, Site 0105 · Contact+34619068153
Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
- Rebeca Lorca Gutierrez, Site 0106 · Contact+3498510800033114
Recruiting
Hospital Universitario de Burgos
Burgos, Spain
- Ana Merino Merino, Site 0107 · Contact+34947281800
Recruiting
Hospital Clinico San Carlos
Madrid, Spain
- Maria Alejandra Restrepo Cordoba, Site 0108 · Contact+34913303944
Recruiting
Hospital Clinico Universitario Virgen de La Victoria
Málaga, Spain
- José Manuel García Pinilla, Site 0103 · Contact+34951032349
Recruiting
Local Institution - 0113
London, Greater London, United Kingdom
- Site 0113 · Contact
Not yet recruiting
Imperial College Healthcare NHS Trust
London, Greater London, United Kingdom
- Amanda Varnava, Site 0115 · Contact+447532199693
Recruiting
University Of Manchester
Manchester, Greater Manchester, United Kingdom
- Andrew Crean, Site 0112 · Contact+441612761234
Recruiting
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, United Kingdom
- Robert Cooper, Site 0111 · Contact+441512281616
Recruiting
Leeds General Infirmary
Leeds, West Yorkshire, United Kingdom
- Alex Simms, Site 0114 · Contact+441133922385
Recruiting
University Hospital of Wales
Cardiff, United Kingdom
- Zaheer Yousef, Site 0116 · Contact+442920716008
Recruiting
Local Institution - 0084
Klagenfurt, Austria
Withdrawn
Local Institution - 0002
Olomouc, Czechia
Withdrawn
Local Institution - 0001
Prague, Czechia
Withdrawn
Local Institution - 0117
Montpellier, France
Withdrawn
Local Institution - 0101
Erlangen, Bavaria, Germany
Withdrawn
Local Institution - 0002
Katowice, Poland
Withdrawn
Local Institution - 0001
Warsaw, Poland
Withdrawn
Local Institution - 0102
Madrid, Spain
Withdrawn
Local Institution - 0110
Birmingham, West Midlands, United Kingdom
Active, not recruiting

Long-term study of people taking mavacamten or other treatments for obstructive hypertrophic cardiomyopathy

What this study is

What's being tested

Study details

Who can join

Monitoring & Endpoints

Study locations (101)

Study team

Bristol-Myers Squibb

Bristol-Myers Squibb

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

First line of the email MUST contain NCT # and Site #.

Frequently asked questions