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)
Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States and European Prospective Registry Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study follows adults with obstructive HCM, a condition where thick heart muscle blocks blood flow and causes symptoms. It tracks usual treatments and health over time in the United States and Europe, including people whose past treatments did not work or caused problems. It looks at mavacamten's safety in both regions and how well it works in Europe.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Give written permission to join and any required permission to use health information. A legal representative may give permission if needed.
- Have obstructive HCM diagnosed using the heart care guidelines for your region.
- US: Have heart muscle thickness of at least 15 mm, or 13 mm with a family history of HCM, not explained only by another condition. The heart's main pumping chamber must not be enlarged, and pressure across its blood exit must be at least 30 mmHg.
- Have a heart ultrasound showing that the heart pumps out at least 55% of its blood with each beat. In the US, this test must be from the past 6 months.
- US: Have symptoms rated NYHA class II–IV, meaning symptoms that limit activity or occur at rest.
- Europe: Have symptoms rated NYHA class II–III, meaning some or major limits on activity. These must be recorded at joining or, if unavailable then, within the prior 6 months.
- Receive usual HCM medicines: beta blockers, certain calcium channel blockers, or disopyramide; receive mavacamten in the US or start it when joining in Europe; or receive no treatment because past treatment failed or caused problems.
Who can't join
- Have a disease that looks like HCM, such as Fabry disease or amyloidosis, or thick heart muscle linked to high blood pressure.
- Have a fixed blockage where blood leaves the heart, such as a narrowed or replaced aortic valve.
- Had surgery or an alcohol procedure to reduce thick heart muscle within the past 6 months. An unsuccessful procedure more than 6 months ago may be allowed.
- Have never taken beta blockers, certain calcium channel blockers, or disopyramide for obstructive HCM.
- US: Receive an experimental HCM drug in a treatment trial when joining, or have ever joined a long-term mavacamten safety extension study.
- Europe: Receive an experimental HCM drug or a drug that targets the heart muscle protein myosin when joining.
- Europe: Have ever joined another HCM registry or a mavacamten study.
- Europe: Have taken mavacamten before.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (60)
AK
- Alaska Heart Institute · Anchorage, AK 99508Ahmed Abuzaid, Site 0023 · Study contact · 907-561-3211More trials in Anchorage
AR
- UAMS · Little Rock, AR 72205-7199Srikanth Vallurupalli, Site 0007 · Study contact · 501-686-5545More trials in Little Rock
AZ
- Pima Heart and Vascular · Tucson, AZ 85704Greg Koshkarian, Site 0025 · Study contact · 000-000-0000More trials in Tucson
CA
- Local Institution - 0037 · La Jolla, CA 92037More trials in La Jolla
- Keck School of Medicine of USC-Usc · Los Angeles, CA 90033Eugene DePasquale, Site 0057 · Study contact · 323-442-6130More trials in Los Angeles
- Stanford Health Care Hospital & Clinics · Palo Alto, CA 94304Matthew Wheeler, Site 0012 · Study contactMore trials in Palo Alto
- University Of California San Francisco Medical Center · San Francisco, CA 94117Theodore Abraham, Site 0021 · Study contactMore trials in San Francisco
CO
- UC Denver, AMC · Aurora, CO 48377David Raymer, Site 0050 · Study contact · 720-848-5300More trials in Aurora
CT
- Local Institution - 0067 · Hartford, CT 06106More trials in Hartford
DC
- MedStar Washington Hospital Center · Washington D.C., DC 20010Patrick Bering, Site 0081 · Study contact · 202-877-5975More trials in Washington D.C.
FL
- Local Institution - 0065 · Jacksonville, FL 32209More trials in Jacksonville
HI
- Local Institution - 0046 · Honolulu, HI 96813More trials in Honolulu
IA
- Local Institution - 0045 · Iowa City, IA 52242More trials in Iowa City
IL
- University of Chicago Dept of Medicine · Chicago, IL 60637Gene Kim, Site 0063 · Study contact · 773-702-9396More trials in Chicago
IN
- Indiana. University · Indianapolis, IN 46202Roopa Rao, Site 0013 · Study contact · 317-962-9700More trials in Indianapolis
- Franciscan Physician Network-Indiana Heart Physicians · Indianapolis, IN 46237George Lolay, Site 0016 · Study contact · 317-893-1712More trials in Indianapolis
MA
- Harvard (Massachusetts General Hospital) · Boston, MA 02114Albree Tower-Rader, Site 0024 · Study contact · 617-724-5434More trials in Boston
- Harvard Medical School - Brigham and Women's Hospital (BWH) · Boston, MA 02215Carolyn Ho, Site 0068 · Study contact · 617-732-5500More trials in Boston
MD
- Local Institution - 0059 · Baltimore, MD 21201More trials in Baltimore
- MedStar Health Research Institute · Baltimore, MD 21218Sandeep Jani, Site 0030 · Study contactMore trials in Baltimore
MI
- Spectrum Health Medical Group · Grand Rapids, MI 49525David Fermin, Site 0073 · Study contact · 616-885-5000More trials in Grand Rapids
- Henry Ford Health System · West Bloomfield, MI 48322Karthikeyan Ananthasubramaniam, Site 0034 · Study contactMore trials in West Bloomfield
MN
- Minneapolis Heart Institute Foundation · Minneapolis, MN 55407Robert Fraser, Site 0010 · Study contact · 612-863-3900More trials in Minneapolis
MO
- St. Luke's Mid-America Heart Institute · Kansas City, MO 64111Michael Nassif, Site 0069 · Study contactMore trials in Kansas City
- Local Institution - 0033 · Kansas City, MO 66160More trials in Kansas City
- Washington University · St Louis, MO 63110Richard Bach, Site 0036 · Study contact · 314-362-1963More trials in St Louis
MS
- Cardiology Associates Research, Llc · Tupelo, MS 38801Barry Bertolet, Site 0062 · Study contact · 904-392-2469More trials in Tupelo
NC
- Focus Clinical Research · Charlotte, NC 28207Aamer Qurehshi, Site 0040 · Study contact · 888-635-0552More trials in Charlotte
- Duke University Health System · Durham, NC 27710Andrew Wang, Site 0022 · Study contactMore trials in Durham
NE
- CHI Health Reseach Center · Omaha, NE 68124Amjad Kabach, Site 0070 · Study contactMore trials in Omaha
NJ
- Hackensack University Medical Center · Hackensack, NJ 07601Dmitry Nemirovsky, Site 0029 · Study contact · 551-996-5870More trials in Hackensack
- Local Institution - 0026 · Morristown, NJ 07960More trials in Morristown
NY
- Bassett Medical Center · Cooperstown, NY 13326Mun Hong, Site 0006 · Study contact · 607-547-4582More trials in Cooperstown
- Local Institution - 0009 · New York, NY 10019More trials in New York
- Mount Sinai Hospital · New York, NY 10029Johanna Contreras, Site 0035 · Study contact · 917-751-5850More trials in New York
- Saint Francis Hospital · Roslyn, NY 11576Allen Jeremias, Site 0075 · Study contact · 631-707-2586More trials in Roslyn
- WMCHealth Advanced Physician Services · Valhalla, NY 10595Srihari Naidu, Site 0053 · Study contact · 914-598-7651More trials in Valhalla
OH
- Christ Hospital Health Network · Cincinnati, OH 45219Wojciech Mazur, Site 0015 · Study contact · 513-721-8881More trials in Cincinnati
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106Anene Clair Ukaigwe, Site 0041 · Study contact · 216-286-1023More trials in Cleveland
- Local Institution - 0003 · Cleveland, OH 44195More trials in Cleveland
PA
- St. Luke's University Health Network · Bethlehem, PA 18015Jamshid Shirani, Site 0043 · Study contact · 718-430-3314More trials in Bethlehem
- Local Institution - 0076 · Lancaster, PA 17603More trials in Lancaster
- University Of Pittsburgh · Pittsburgh, PA 15213Timothy Wong, Site 0027 · Study contactMore trials in Pittsburgh
- Geisinger Health System · Wilkes-Barre, PA 18711Vernon Mascarenhas, Site 0056 · Study contact · 570-808-6020More trials in Wilkes-Barre
SC
- Prisma Health - Upstate · Greenville, SC 29605Josh Doll, Site 0042 · Study contact · 864-455-7727More trials in Greenville
TN
- Tristar Centennial Medical Ctr · Nashville, TN 37203Bryan Doherty, Site 0048 · Study contact · 347-949-3060More trials in Nashville
- Saint Thomas Health · Nashville, TN 37205-2018Mark Zenker, Site 0019 · Study contact · 615-269-4545More trials in Nashville
TX
- North Texas Cardiology Center · Dallas, TX 75208Manavjot Sidhu, Site 0018 · Study contact · 214-933-7430More trials in Dallas
- Baylor Scott & White Research Institute · Dallas, TX 75246Robert Gottlieb, Site 0008 · Study contactMore trials in Dallas
- The Methodist Hospital, Methodist Cancer Cencer · Houston, TX 77030Sherif Nagueh, Site 0058 · Study contact · 713-441-2850More trials in Houston
- BI Research Center · Houston, TX 77084Asif Akhtar, Site 0039 · Study contact · 281-944-3610More trials in Houston
- Baylor Scott & White The Heart Hospital Plano · Plano, TX 75093David Rawitscher, Site 0028 · Study contact · 469-800-6390More trials in Plano
- Baylor Scott & White Medical Centre - Temple · Temple, TX 76508Vinh Nguyen, Site 0051 · Study contact · 254-724-5119More trials in Temple
VA
- The Rector and Visitors of the Univ of Virginia · Charlottesville, VA 22908Christopher Kramer, Site 0011 · Study contact · 434-982-0853More trials in Charlottesville
- VCU Medical Center · Richmond, VA 23298Mohammed Makkiya, Site 0080 · Study contact · 804-828-9989More trials in Richmond
- Carilion Clinic; Virginia Tech-Carilion School of Medicine · Roanoke, VA 24014Ali Hama Amin, Site 0044 · Study contact · 540-982-8204More trials in Roanoke
WA
- Virginia Mason Medical Center · Seattle, WA 98101Mariko Harper, Site 0052 · Study contact · 206-341-1111More trials in Seattle
WI
- Local Institution - 0004 · Madison, WI 53792More trials in Madison
- Medical College of Wisconsin, Inc (PI Address) · Milwaukee, WI 53226Abhinav Sharma, Site 0054 · Study contact · 414-805-6000More trials in Milwaukee
WV
- WVU Hospitals · Morgantown, WV 26506Christopher Bianco, Site 0055 · Study contact · 304-598-4000More trials in Morgantown