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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)

Sponsor: Bristol-Myers Squibb

NCT ID: NCT05489705

View on ClinicalTrials.gov ↗

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.

Obstructive Hypertrophic Cardiomyopathy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

with positive

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
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

Where Is This Study? (7 UK sites)

Local Institution - 0113

London SW3 6NP, United Kingdom

NOT_YET_RECRUITING

Imperial College Healthcare NHS Trust

London W6 8RF, United Kingdom

Recruiting
Site contact (verified)
Amanda Varnava, Site 0115+447532199693

University Of Manchester

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)
Andrew Crean, Site 0112+441612761234

Liverpool Heart and Chest Hospital

Liverpool L14 3PE, United Kingdom

Recruiting
Site contact (verified)
Robert Cooper, Site 0111+441512281616

Local Institution - 0110

Birmingham B15 2GW, United Kingdom

ACTIVE_NOT_RECRUITING

Leeds General Infirmary

Leeds LS1 3EX, United Kingdom

Recruiting
Site contact (verified)
Alex Simms, Site 0114+441133922385

University Hospital of Wales

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)
Zaheer Yousef, Site 0116+442920716008

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

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

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-08