Follows adults with thickened heart muscle and mavacamten or other treatments
Observes people with blocked-flow heart thickening who take mavacamten or other medicines.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- Burgos, El Palmar, Madrid, Majadahonda, Málaga, Oviedo, and Palma de Mallorca, SpainSee the 8 sitesAlso in 8 other countries, 93 sites
- Trial code
- 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)
- Status
- Recruiting
- People taking part
- 1,700 people, planned
- Started
- 16 Aug 2022
- Expected to end
- 17 Aug 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Mavacamten
- Non-mavacamten symptomatic oHCM therapy
- Record updated
- 19 August 2026
Who can take part
AI summary
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)
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- ≥ 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)
Who cannot take part
- 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
Where in Spain
Also in 8 other countries, 93 sites
- Hospital Universitario De BurgosBurgos, SpainContact: Ana Merino Merino, Site 0107Taking people
- Hospital Universitario Virgen de la ArrixacaEl Palmar, SpainContact: Juan Ramon Gimeno Blanes, Site 0105Taking people
- Hospital Clínico San CarlosMadrid, SpainContact: Maria Alejandra Restrepo Cordoba, Site 0108Taking people
- MadridHospital not named in the registryNo longer taking part
- Hospital Universitario Puerta de Hierro - MajadahondaMajadahonda, SpainContact: Pablo García Pavia, Site 0104Taking people
- Hospital Clinico Universitario Virgen de La VictoriaMálaga, SpainContact: José Manuel García Pinilla, Site 0103Taking people
- Hospital Universitario Central De AsturiasOviedo, SpainContact: Rebeca Lorca Gutierrez, Site 0106Taking people
- Hospital Fundacion Son LlatzerPalma de Mallorca, SpainContact: Tomas Ripoll, Site 0109Taking people
About the trial
What the trial wants to find out
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
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.
The 2 groups in the trial
- Mavacamten
Participants will receive mavacamten as prescribed by a physician according to standard of care for symptomatic oHCM
- Beta-blocker (BB) / non-dihydropyridine (non-DHP) calcium channel blocker (CCB) / disopyramide
Participants will receive BB/non-DHP CCB/disopyramide as prescribed by a physician according to standard of care for symptomatic oHCM
Treatment: Non-mavacamten symptomatic oHCM therapy
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States and European Prospective Registry Study
- Plain-language title
- Follows adults with thickened heart muscle and mavacamten or other treatmentsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 August 2026