Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:55 AM
Study NCT ID:
NCT07381894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-02
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicentre Hypertrophic Cardiomyopathy Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Key Efficacy Parameters (LVOT Gradient)', 'timeFrame': '3-5 years', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Incidence of Clinically Significant Arrhythmias', 'timeFrame': '5 years', 'description': 'Incidence rates of new-onset or recurrent atrial fibrillation (AF)/atrial flutter (AFL) and sustained/non-sustained ventricular tachycardia (VT/NSVT) episodes.'}, {'measure': 'Correlation of Genotype and Imaging with Clinical Outcomes', 'timeFrame': '5 years', 'description': '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.'}, {'measure': 'Change in Serum Biomarker', 'timeFrame': '3-5 years', 'description': 'Response in cardiac biomarker profile (nT-proBNP measured in ng/L and serum troponin measured in ng/L) in response to treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertrophic cardiomyopathy'], 'conditions': ['Hypertrophic Cardiomyopathy (HCM)']}, 'descriptionModule': {'briefSummary': '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.\n\nWhile 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.\n\nParticipants 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', 'detailedDescription': 'Study Overview:\n\nThe 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.\n\nPrimary Objectives:\n\nDescribe the natural history and treatment response of HCM across UK centers, including the utilisation and outcomes of medical therapies, including cardiac myosin inhibitors (CMIs).\n\nSecondary Objectives:\n\nDetermine 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.\n\nStudy Population and Procedures:\n\nEligible participants include adults (above the age of 18 years old) with a definite clinical diagnosis of HCM, not explained by abnormal loading conditions.\n\nData 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.\n\nData Management: Participants are pseudonymized with a unique study ID and entered into a secure database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a confirmed diagnosis of hypertrophic cardiomyopathy will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Hypertrophic Cardiomyopathy (HCM) clinically and not solely explained by abnormal loading conditions (e.g., significant hypertension, valvular disease\n\nExclusion Criteria:\n\n* Participants who do not fulfil the imaging and clinical diagnostic criteria of HCM'}, 'identificationModule': {'nctId': 'NCT07381894', 'briefTitle': 'Multicentre Hypertrophic Cardiomyopathy Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Multicentre Hypertrophic Cardiomyopathy Registry', 'orgStudyIdInfo': {'id': '363346'}}, 'contactsLocationsModule': {'locations': [{'zip': 'M23 9LT', 'city': 'Manchester', 'country': 'United Kingdom', 'contacts': [{'name': 'Andrew Crean', 'role': 'CONTACT', 'email': 'hcmresearch@manchester.ac.uk', 'phone': '+441619987070'}], 'facility': 'University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist', 'investigatorFullName': 'Wei Jun How', 'investigatorAffiliation': 'University of Manchester'}}}}