Hypertrophic Cardiomyopathy (HCM)GRADIENTNCT07295613
ReGistry of hypeRtrophic cArDIomyopathy: Regional fEatures, geNeTics and Course
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Central State Medical Academy at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- How many people
- 1,400 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Nov 2023to 1 Oct 2028
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: adult and pediatric patients with HCM
Who may be able to join
- 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:
Show all 24Show fewer
- 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
Who cannot join
- 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"
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites
Central State Medical Academy
Moscow, Moscow Reg, 1213059
CGMA
Moscow
About this study
Official title: Multicenter Prospective Registry of Patients With Hypertrophic Cardiomyopathy
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
Read the detailed description
This study is observational registry of patients with HCM in Russian Federation. The study seeks to elucidate disease progression, identify contributing clinical factors, and explore new as well as previously established associations between genetic and acquired determinants and clinical features of HCM.The Additional Objectives of the Study are:
- To evaluate the natural progression of HCM in non-operated patients who have indications for myectomy and in high-risk patients for SCD, who have not been implanted with an ICD.
- To clarify the relationship between pediatric and adult HCM by constructing large pedigrees, including clinically and genetically examined relatives.
- To evaluate real-world clinical practices, both surgical and therapeutic, in the management of LV obstruction.
- To investigate the impact of comorbidities on phenotypic expression of HCM.
- To establish a group of national HCM experts and centers of excellence. We plan to include 1400 patients with HCM in the study.The examination of patients includes the collection of clinical information, ECG, EchoCG, Holter ECG monitoring, etc.• During follow-up period, patients or their relatives will be contacted by phone at least once every 12 months
- At follow-up visits, information regarding the study endpoints, ant medical examinations, and interventions that have occurred since the time of enrollment will be collected. Investigators are encouraged to make every effort to obtain official medical records that document these endpoints and any interventions that have taken place.
The genetic study aims to identify the causative genetic variants associated with HCM in enrolled patients (probands). The genetic testing will be conducted using new-generation sequencing (NGS) with target gene panels. In the study cohort of patients, an analysis of the effect of common genetic variants, identified based on the literature or GWAS, on the course of HCM will be conducted. In the study cohort (partially or entirely), genome-wide sequencing might be performed to replicate the significance of existing variants and to identify new genetic determinants that define the development of the HCM phenotype.
A comparative analysis of different parameters will be performed across various subgroups, categorized by the following characteristics (but not limited to them):
- Sex
- Age at first diagnosis
- Proband or relative status
- Presence of LV obstruction
- Morphological type of HCM
- Presence of comorbidities
- Presence of mutations or VUSs in sarcomere genes
In addition to the clinical and genetic spectrum and endpoints, the rate and type of diagnostic and treatment procedures related to HCM will be assessed.
In cases where the diagnosis of HCM was reconsidered or declined based on the results of additional investigations after enrollment, such patients will not be included in the prognosis analysis. However, they will be described in the clinical and genetic profile of the study population.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- genetic, epidemiology, Hypertrophic Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
death from any cause
Measured: 3 years
Secondary outcomes (1)
nonfatal events
- Appropriate and non-appropriate ICD shocks
- Successful resuscitation
- Progression of dyspnea to class III/IV according by NYHA
- A reduction in LV EF to less than 50%
- Hospitalization due to HF requiring parenteral diuretics and/or inotropic therapy
- LVAD implantation
- Heart transplantation or being on the waiting list
- Septal reduction therapy
- Non-fatal ischemic strokes
- New onset AF
- New onset non-sustained VT
- New onset Sustained VT
- New onset syncope (highly likely arrhythmogenic)
- Other non-fatal CV events, including but not limited to MI and pulmonary embolism.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Nov 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 1,400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Central State Medical Academy
- Sponsor type
- University, hospital or other
- Collaborators
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Responsible party
- Principal investigator, Zateyshchikov Dmitry, MD, PhD, Central State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295613
- Sponsor's protocol ID
- CGMA 4/1/2023
- Acronym
- GRADIENT
- Status last verified
- Dec 2025
- First submitted
- 13 Apr 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Registry of Patients With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07295613
- Acronym / sponsor ID
- GRADIENT / CGMA 4/1/2023
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- genetic, epidemiology, Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Central State Medical AcademyUniversity, hospital or other
- Collaborators
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is observational registry of patients with HCM in Russian Federation. The study seeks to elucidate disease progression, identify contributing clinical factors, and explore new as well as previously established associations between genetic and acquired determinants and clinical features of HCM.The Additional Objectives of the Study are:
- To evaluate the natural progression of HCM in non-operated patients who have indications for myectomy and in high-risk patients for SCD, who have not been implanted with an ICD.
- To clarify the relationship between pediatric and adult HCM by constructing large pedigrees, including clinically and genetically examined relatives.
- To evaluate real-world clinical practices, both surgical and therapeutic, in the management of LV obstruction.
- To investigate the impact of comorbidities on phenotypic expression of HCM.
- To establish a group of national HCM experts and centers of excellence. We plan to include 1400 patients with HCM in the study.The examination of patients includes the collection of clinical information, ECG, EchoCG, Holter ECG monitoring, etc.• During follow-up period, patients or their relatives will be contacted by phone at least once every 12 months
- At follow-up visits, information regarding the study endpoints, ant medical examinations, and interventions that have occurred since the time of enrollment will be collected. Investigators are encouraged to make every effort to obtain official medical records that document these endpoints and any interventions that have taken place.
The genetic study aims to identify the causative genetic variants associated with HCM in enrolled patients (probands). The genetic testing will be conducted using new-generation sequencing (NGS) with target gene panels. In the study cohort of patients, an analysis of the effect of common genetic variants, identified based on the literature or GWAS, on the course of HCM will be conducted. In the study cohort (partially or entirely), genome-wide sequencing might be performed to replicate the significance of existing variants and to identify new genetic determinants that define the development of the HCM phenotype.
A comparative analysis of different parameters will be performed across various subgroups, categorized by the following characteristics (but not limited to them):
- Sex
- Age at first diagnosis
- Proband or relative status
- Presence of LV obstruction
- Morphological type of HCM
- Presence of comorbidities
- Presence of mutations or VUSs in sarcomere genes
In addition to the clinical and genetic spectrum and endpoints, the rate and type of diagnostic and treatment procedures related to HCM will be assessed.
In cases where the diagnosis of HCM was reconsidered or declined based on the results of additional investigations after enrollment, such patients will not be included in the prognosis analysis. However, they will be described in the clinical and genetic profile of the study population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adult and pediatric patients with HCM
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (3 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all-cause mortality
Time frame: 3 years
death from any cause
1 secondary outcome
nonfatal events
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Central State Medical Academy at 2 sites in Russia.
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 24 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025.