Multicentre Hypertrophic Cardiomyopathy Registry

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

Study Overview

• Status: Recruiting
• Conditions: Hypertrophic Cardiomyopathy (HCM)

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.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9LT
    • Recruiting
    • University of Manchester
    • Contact: Andrew Crean; Phone Number: +441619987070; Email: hcmresearch@manchester.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3-5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years
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.	5 years
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	3-5 years

Collaborators and Investigators

• Sponsor: University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: hypertrophic cardiomyopathy
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 363346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No