At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Mavacamten (drug), Non-mavacamten symptomatic oHCM therapy (drug)
- How long the study runs
- Study runs about 84 months (dates as stated)
- About the drug or intervention
- Mavacamten — drug: As per product label · Non-mavacamten symptomatic oHCM therapy — drug: Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label
- Patient visit burden
- Not specified by the sponsor
In plain English
This study collects information over time from adults with symptomatic obstructive hypertrophic cardiomyopathy (a condition where the heart muscle thickens and blocks blood flow) who are receiving treatments such as beta blockers, certain calcium channel blockers, disopyramide, or mavacamten, or who cannot take these treatments. It looks at patients' characteristics, the treatments they receive, and their long-term health outcomes. It has two parts: one in the United States and one in Europe. The sponsor is Bristol-Myers Squibb.
Who can take part
- Adults aged 18 or over who can give written informed consent (or a legal representative can give consent)
- United States part: diagnosed with obstructive HCM according to 2020 American guidelines, with heart wall thickness of 15 mm or more (or 13 mm or more with a family history of HCM) and a blockage measure (LVOT gradient) of 30 mmHg or more at rest or when provoked
- United States part: pumping strength of the heart (LVEF) of 55% or more on a heart scan (echocardiogram) in the last 6 months, and symptoms of NYHA class II to IV (symptoms such as breathlessness that limit activity)
- European part: diagnosed with obstructive HCM according to the most recent European and American guidelines, LVEF of 55% or more on a heart scan (TTE), and NYHA class II to III symptoms at enrolment or within the previous 6 months
- Taking beta blockers, non-dihydropyridine calcium channel blockers, disopyramide, or mavacamten (Europe: starting mavacamten at enrolment) as part of normal care, or having no treatment because earlier treatments did not work or caused side effects
Who may not be able to
- Having a condition that mimics HCM (such as Fabry disease or amyloidosis), or heart thickening caused by high blood pressure
- Having a fixed blockage of the heart's outflow tract, such as narrowing or replacement of the aortic valve
- Having had invasive septal reduction treatment (surgery or alcohol septal ablation) within 6 months before joining; people whose earlier procedure failed more than 6 months ago may still join
- Never having had any treatment for obstructive HCM
- United States part: taking an experimental treatment for HCM in another clinical trial at enrolment, or having taken part or currently taking part in a long-term mavacamten safety study (such as EXPLORER-HCM, MAVA-LTE, PIONEER-OLE, VALOR-HCM, or MAVERICK)
- European part: taking an experimental treatment or any cardiac myosin inhibitor for HCM at enrolment, taking part in other HCM registries (such as TORCH, REMY, or EU-PASS) or any mavacamten study (such as EXPLORER-HCM, MAVA-LTE, PIONEER-OLE, VALOR-HCM, MAVERICK, or MEMENTO), or having been treated with mavacamten before
What taking part involves
- • This is an observational (registry) study, so you continue your normal care rather than receiving an assigned study treatment
- • Treatments recorded include beta blockers, non-dihydropyridine calcium channel blockers, disopyramide, and mavacamten (Europe: mavacamten started at enrolment)
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,700
- Started
- 2022-08-16
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for obstructive hypertrophic cardiomyopathy
- • Clinical study - 1,700 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with obstructive hypertrophic cardiomyopathy
Where?
- • London - Local Institution - 0113
- • London - Imperial College Healthcare NHS Trust
- • Manchester - University Of Manchester
- • Liverpool - Liverpool Heart and Chest Hospital
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ privacy authorization
- ✓ (eg
- ✓ of obstructive HCM with invasive septal reduction (surgical myectomy
What the study is looking for
- ✓Inclusion Criteria
- ✓≥ 18 years of age at the time of agreement to take part.
- ✓United States Sub-Study
- ✓Diagnosis of obstructive HCM consistent with 2020 American Heart Association/American College of Cardiology...
- ✓Has documented LVEF of ≥ 55% recorded by echocardiography within the last 6 months.
See the full criteria
Where Is This Study? (7 UK sites)
Local Institution - 0113
London SW3 6NP, United Kingdom
Imperial College Healthcare NHS Trust
London W6 8RF, United Kingdom
University Of Manchester
Manchester M13 9WL, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool L14 3PE, United Kingdom
Local Institution - 0110
Birmingham B15 2GW, United Kingdom
Leeds General Infirmary
Leeds LS1 3EX, United Kingdom
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
How to Get in Touch
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Sponsor contactCONTACT
First line of the email MUST contain NCT # and Site #.
Sponsor contactCONTACT
