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Hypertrophic Cardiomyopathy (HCM)NCT07381894

Multicentre Hypertrophic Cardiomyopathy Registry

An observational study of Hypertrophic Cardiomyopathy (HCM), run by University of Manchester at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Hypertrophic cardiomyopathy (HCM) is the most common inherited heart condition, affecting approximately 1 in 500 people. It causes the heart muscle to thicken, which can lead to blockages in blood flow (left ventricular outflow tract obstruction), shortness of breath, and an increased risk of heart failure or sudden… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Hypertrophic Cardiomyopathy (HCM)
How many people
2,500 participants
Where
1 siteUnited Kingdom
Study dates
1 Apr 2026to 1 Jan 2029
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with a confirmed diagnosis of hypertrophic cardiomyopathy will be recruited.

Who may be able to join

  • Confirmed diagnosis of Hypertrophic Cardiomyopathy (HCM) clinically and not solely explained by abnormal loading conditions (e.g., significant hypertension, valvular disease

Who cannot join

  • Participants who do not fulfil the imaging and clinical diagnostic criteria of HCM

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting

  • University of Manchester

    Manchester, M23 9LT

    Andrew Crean, +441619987070, hcmresearch@manchester.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Hypertrophic cardiomyopathy (HCM) is the most common inherited heart condition, affecting approximately 1 in 500 people. It causes the heart muscle to thicken, which can lead to blockages in blood flow (left ventricular outflow tract obstruction), shortness of breath, and an increased risk of heart failure or sudden cardiac arrest.

While standard treatments exist and new targeted medications (cardiac myosin inhibitors) have recently been approved, doctors still need better data to predict which treatments will work best for each individual patient. This national registry based in the UK is a secure database that collects health information from HCM patients across multiple NHS hospital sites in the UK over several years.

Participants in this study will have their routine health information collected from their medical records, including details from heart scans (echocardiograms and MRIs), blood tests, and genetic information. With this HCM registry, we aim to improve disease understanding and risk prediction, paving the way for more personalised treatment plans for the HCM community in the future

Read the detailed description

Study Overview:

The National Hypertrophic Cardiomyopathy (HCM) Registry is a prospective, multicentre, observational registry designed to characterize contemporary UK clinical practice and provide longitudinal, granular phenotyping of patients with HCM. The study aims to recruit approximately 2,500 participants across multiple NHS hospitals over a 5-year enrollment period.

Primary Objectives:

Describe the natural history and treatment response of HCM across UK centers, including the utilisation and outcomes of medical therapies, including cardiac myosin inhibitors (CMIs).

Secondary Objectives:

Determine the incidence and predictors of clinically significant arrhythmias. Define genotype-phenotype correlations. Correlate serum biomarkers (e.g., NT-proBNP, high-sensitivity cardiac troponin) and multimodality imaging metrics (echocardiographic strain, CMR-derived scar burden) with clinical outcomes.

Study Population and Procedures:

Eligible participants include adults (above the age of 18 years old) with a definite clinical diagnosis of HCM, not explained by abnormal loading conditions.

Data collection occurs during routine clinical visits with collected variables including demographics, comorbidities, medications, 12-lead ECG, biomarkers, echocardiography, CMR parameters, and device status (if available). All clinical care remains at the discretion of the treating physician.

Data Management: Participants are pseudonymized with a unique study ID and entered into a secure database.

Keywords
hypertrophic cardiomyopathy
Medical subject headings
Cardiomyopathy, Hypertrophic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Key Efficacy Parameters (LVOT Gradient)

    Change in left ventricular outflow tract (LVOT) gradient (measured echocardiographically in mmHg) at both resting and stress condition in obstructive cases in response to treatment

    Measured: 3-5 years

Secondary outcomes (3)

  1. Incidence of Clinically Significant Arrhythmias

    Incidence rates of new-onset or recurrent atrial fibrillation (AF)/atrial flutter (AFL) and sustained/non-sustained ventricular tachycardia (VT/NSVT) episodes.

    Measured: 5 years

  2. Correlation of Genotype and Imaging with Clinical Outcomes

    Correlation analysis to define genotype-phenotype relationships, and the relationship between imaging-derived parameters such as scar burden (Late Gadolinium Enhancement, LGE) and clinical outcomes.

    Measured: 5 years

  3. Change in Serum Biomarker

    Response in cardiac biomarker profile (nT-proBNP measured in ng/L and serum troponin measured in ng/L) in response to treatment

    Measured: 3-5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start1 Apr 2026
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
2,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07381894
Sponsor's protocol ID
363346
Status last verified
Dec 2025
First submitted
22 Dec 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertrophic Cardiomyopathy (HCM), run by University of Manchester at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Key Efficacy Parameters (LVOT Gradient) (time frame: 3-5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07381894.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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