Follows adults with thickened heart muscle and mavacamten or other treatments
Observes people with blocked-flow heart thickening who take mavacamten or other medicines.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Amiens, Haguenau, Lille, Montpellier, Poitiers, Saint-Herblain, and Toulon, FranceSee the 7 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with symptomatic obstructive hypertrophic cardiomyopathy (a thickened heart muscle that blocks blood flow out of the heart) in the United States or Europe. They receive mavacamten or other treatment, or no treatment after earlier treatment failed or was not tolerated.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Obstructive hypertrophic cardiomyopathy with symptoms (NYHA class II-IV in the US, class II-III in Europe) and LVEF of 55% or higher on a heart ultrasound.
- Earlier treatment
- Must be getting beta blockers, non-DHP calcium channel blockers, disopyramide or mavacamten as part of routine care, or be on no treatment because earlier treatment failed or was not tolerated. People never treated for this condition cannot join. In Europe, people previously treated with mavacamten cannot join.
- Biomarker or test result
- US: LV wall thickness of 15 mm or more (13 mm or more with a family history of HCM) and a peak LVOT gradient of 30 mmHg or more at rest or with provocation.
Main reasons for not taking part
- Known look-alike heart diseases such as Fabry disease or amyloidosis, or thickening linked to high blood pressure
- Fixed blockage of the heart outflow, such as aortic valve stenosis or replacement
- Septal reduction surgery or alcohol ablation within the last 6 months
- Taking an investigational drug for this condition in another trial
- Earlier or current enrolment in a mavacamten study (US and Europe) or other HCM registries (Europe)
Read by machine on 9 November 2026.
Where in France
- Chu Amiens PicardieAmiens, FranceTaking people
- Centre Hospitalier HaguenauHaguenau, FranceTaking people
- Hopital Saint Vincent de PaulLille, FranceTaking people
- MontpellierMontpellier, FranceNo longer taking part
- CHU de Poitiers - Hôpital de la MilétriePoitiers, FranceTaking people
- CHU Nantes - Hopital Nord LaënnecSaint-Herblain, FranceTaking people
- Hopital Sainte MusseToulon, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT05489705
- Record updated
- 19 August 2026
- Original description
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.Read full original descriptionShow less
Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States and European Prospective Registry Study
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.
Inclusion: ≥ 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: 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; 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.