NCT07295613Enrolling by invitation
ReGistry of hypeRtrophic cArDIomyopathy: Regional fEatures, geNeTics and Course
Multicenter Prospective Registry of Patients With Hypertrophic Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 13 Apr 2025
- Start date
- 1 Nov 2023
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Central State Medical Academy
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07295613
What you commit to
- Study type: Observational
- Planned participants: 1400
- From 1 Nov 2023 to the primary completion date, 1 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled arterial hypertension of 2nd - 3rd degree with mild/moderate (\< 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"
Who the study is looking for
- 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
- 1st degree of AH: The same ECHO/CMR criteria as patients without AH
- 2nd 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
- T wave inversions in at least 2 adjacent leads: ≥ 3mm in V3-V6, I, aVL or ≥ 5mm in II, III, aVF
- Pathological Q waves (\> 25% of R) in at least 2 adjacent leads: II, III, aVF (in the absence of left anterior hemiblock) or V1-V4, or I, aVL, V5-V6
- \*Presence at least one of the following:
- Sokolow-Lyon index (S in V1 + R in V5 or V6) \> 35mm
- R or S in limb leads ≥ 20mm
- S in V1 or V2 ≥ 30mm
- R in V5 or V6 ≥ 30mm HCM Criteria for Children and Adolescents \< 18 Years
- End-diastolic LV wall thickness in any segment \> 2.5 standard deviations (\> 2.5 z-score) above the norms for the index gender, age and weight (or body surface area) in asymptomatic children/adolescents without a family history of HCM
- End-diastolic LV wall thickness in any segment \> 2.0 standard deviations (\> 2.0 z-score) above the norms for the index gender, age and weight (or body surface area) in children/adolescents with a family history of HCM or a positive genetic test
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Central State Medical Academy Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| CGMA Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.