ReGistry of hypeRtrophic cArDIomyopathy: Regional fEatures, geNeTics and Course

NCT07295613 | Enrolling By Invitation

• 1 other identifier: CGMA 4/1/2023
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 2

Brief Summary

This study is envisioned as the very first of its kind in the Russian Federation, aiming to provide a comprehensive characterization of the clinical spectrum and disease burden, focusing on the epidemiology and progression of HCM in the largest cohort of adult and pediatric patients from this region. This registry will help increase knowledge of the epidemiology and prevalence of HCM, ultimately improving diagnosis and management. To assess the feasibility of new interventions, understanding the epidemiological profile of patients with HCM is essential. Clinical characteristics, imaging patterns, and outcomes may vary across different geographic regions. Completing this registry will enhance our understanding of the disease in Russia, and promote measures that modify the natural history of HCM

Conditions

Hypertrophic Cardiomyopathy (HCM)

Keywords

genetic; epidemiology; Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  death from any cause

  3 years

Secondary Outcomes (1)

• nonfatal events

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult and pediatric patients with HCM

You may qualify if:

• Any age
• Signed informed consent form (ICF) for participation in the study, including genetic testing
• Meets the criteria for HCM HCM Criteria for Probands ≥ 18 Years Based on ECHO or CMR
• End-diastolic LV wall thickness ≥ 15mm in any segment of the LV HCM Criteria for Probands ≥ 18 Years with Arterial Hypertension
• st degree of AH: The same ECHO/CMR criteria as patients without AH
• nd and 3rd degrees of AH:
• Asymmetric LV hypertrophy: the ratio of septum / LV PW ≥ 1.5 or apical HCM
• If asymmetry \< 1.5, the wall thickness must be ≥ 20mm
• For all patients with arterial hypertension, the presence of at least one of the following ECG changes is obligatory:
• Pathological "dagger" Q wave
• T-wave inversion ≥ 3mm in ≥ 2 adjacent leads
• Poor R progression / QS / RV1 \> RV2 \< RV3 in V1-V4
• HCM Criteria for First-degree Relatives ≥ 18 Years Based on ECHO or CMR and ECG:
• End-diastolic LV wall thickness ≥ 13mm in any segment and/or ECG changes in the absence of CAD, such as (at least one of the following):
• Quantitative signs of LV hypertrophy\* + repolarization changes

You may not qualify if:

• Uncontrolled arterial hypertension of 2nd - 3rd degree with mild/moderate (\&lt; 20mm) or symmetric LV hypertrophy or a "normal" ECG
• Hemodynamically significant congenital or acquired valve heart disease
• Established diagnosis of metabolic, infiltrative, endocrine, or other diseases known as "phenocopies of HCM"

Sponsors & Collaborators

• Central State Medical Academy: lead
• Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health: collaborator

Study Sites (2)

Central State Medical Academy

Moscow, Moscow Reg, 1213059, Russia

Location

CGMA

Moscow, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for subsequent DNA extraction and genetic analysis can be collected at any time of the day, regardless of food intake. Venous blood is collected from the cubital vein in sterile vacutainer tubes with EDTA reagent (purple caps). It is optimal to use 3 4.5 ml tubes. The tubes should be labeled with the patient\&amp;amp;amp;#39;s last name and initials, individual code at the participating center, collection date, and sample type (A, B, or C). After blood collection, the tubes should be frozen at an optimal temperature of (-) 200C. The blood is not centrifuged.

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of the department of therapy, cardiology and functional diagnostic

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: December 19, 2025
• Study Start: November 1, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)