Apical Hypertrophic CardiomyopathyNCT06977646
Surgical Treatment of the Patients With Restrictive Phenotype of the Hypertrophic Cardiomyopathy Without LVOT Obstruction
An observational study of Apical Hypertrophic Cardiomyopathy, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial summary
Hypertrophic cardiomyopathy - is an inherited disease characterized by pronounced genetic and phenotypic heterogeneity. There are two most common anatomic variants of cardiac hypertrophy: subaortic and submitral phenotypes. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Apical Hypertrophic Cardiomyopathy
- What is being tested?
- Surgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstruction
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2025to 1 Dec 2025
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include all patients meeting the inclusion criteria treated in the period from 2017 to 2024 at the Petrovsky National Research Centre of Surgery and the Federal Cardiac Surgery Center in Astrakhan
Who may be able to join
- Hypertrophic apical cardiomyopathy according to medical records
- Surgical left ventricular remodeling performed
Who cannot join
- LVOT gradient greater than 30 mmHg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Petrovsky National Research Centre of Surgery
Moscow, Moscow, 119991
About this study
Official title: Retrospective Study of the Surgical Treatment Restrictive Form of the Hypertrophic Cardiomyopathy Without of the Left Ventricular Outflow Tract Obstruction
Hypertrophic cardiomyopathy - is an inherited disease characterized by pronounced genetic and phenotypic heterogeneity. There are two most common anatomic variants of cardiac hypertrophy: subaortic and submitral phenotypes. Subaortic phenotype is characterized by hypertrophy of the basal parts of the heart, mainly in the interventricular septum (IVS), manifesting by a high pressure gradient in the LVOT. Submitral phenotype is characterized by localization of hypertrophic zone downward to the apex and apical phenotype is without a pressure gradient in the LVOT.
The morphology, nature of hemodynamic abnormalities not well studied in patients with apical phenotype of HCM, and surgical treatment are controversial, and for those patients with advanced stage of the HF the orthotopic heart transplantations (HTx) is usually considered.
Read more
One of the surgical techniques available for this category of patients is apical myectomy. The main goal of this intervention is increasing the left ventricular volume and improving of the LV compliance with an increase of the diastolic relaxation. Limited data of such procedures in HCM patients were already published but it still requires further investigation on larger cohort of patients.
In this study, the investigators hypothesize that along with left ventricular septal hypertrophy, a small cavity is formed in patients with submittal-apical phenotype due to an increased number of hypertrophied papillary muscles. They are displaced to the apex and tightly fixed both among themselves and to the left ventricular walls. This causes a significant reduction in diastolic volume and left ventricular relaxation capacity. The present study will analyze the experience of performing resection of hypertrophied trabeculae and mobilization of papillary muscles performed through the aorta. Throw this approach procedure can be done without the need for traumatic access and suturing in the apex of the left ventricle.
- Conditions
- Apical Hypertrophic Cardiomyopathy
- Being tested
- Surgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstruction
- Keywords
- Apical hypertrophic cardiomyopathy, Midventricular obstruction and cavity obliteration, Septal myectomy, hypertrophic cardiomyopathy, sudden cardiac death
- Medical subject headings
- Apical Hypertrophic Cardiomyopathy, Cardiomyopathy, Hypertrophic, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstructionProcedure or surgery
The proposed intervention is a variation of classical myectomy, but unlike it, the main substrate for resection is not only the hypertrophied interventricular septum, but the abnormal papillary muscles and interpapillary trabeculae in the left ventricular cavity
| Study group | Role | What they receive |
|---|---|---|
| Patients with hypertrophic apical cardiomyopathy undergoing surgical interventions | Patients who underwent surgery for apical hypertrophic cardiomyopathy without significant left ventricular outflow tract obstruction. Patients with transapical surgical access will not be included in the study. Receives: Procedure: Surgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality after undergoing trans aortic surgical left ventricular remodeling
Binary value: of alive/dead
Measured: Assessment by medical records during the first 28 days after surgical intervention
Secondary outcomes (4)
left ventricular diastolic dysfunction
Diastolic left ventricular function relying on echo protocols. E/A ratio as an equation of an early transmitral flow (E wave) and a late flow with atrial contraction (A wave). An E/A ratio less than 0.75 or greater than 1.5 indicates dyastolic disfunction.
Measured: Perioperative/Periprocedural
Heart Failure (NYHA)
Functional class of heart failure according to New York Heart Association (NYHA) Functional Classification of heart failure
Measured: 1 month after surgery
Need for mechanical circulation in the postoperative period
Binary value: yes/no
Measured: Perioperative/Periprocedural
Freedom from re-interventions after surgical left ventricular remodeling
Binary value yes/no According to available medical records for the entire follow-up period
Measured: hrough study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jun 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical Hypertrophic CardiomyopathyStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergey L Dzemeshkevich, MD, PhD, Prof., Principal investigator, Petrovsky National Research Centre of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977646
- Sponsor's protocol ID
- ApHCM-001
- Status last verified
- Jul 2025
- First submitted
- 7 May 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the Surgical Treatment Restrictive Form of the Hypertrophic Cardiomyopathy Without of the Left Ventricular Outflow Tract Obstruction
- ClinicalTrials.gov ID
- NCT06977646
- Acronym / sponsor ID
- ApHCM-001
- Conditions
- Apical Hypertrophic Cardiomyopathy
- Keywords
- Apical hypertrophic cardiomyopathy, Midventricular obstruction and cavity obliteration, Septal myectomy, hypertrophic cardiomyopathy, sudden cardiac death
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 May 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.
Hypertrophic cardiomyopathy - is an inherited disease characterized by pronounced genetic and phenotypic heterogeneity. There are two most common anatomic variants of cardiac hypertrophy: subaortic and submitral phenotypes. Subaortic phenotype is characterized by hypertrophy of the basal parts of the heart, mainly in the interventricular septum (IVS), manifesting by a high pressure gradient in the LVOT. Submitral phenotype is characterized by localization of hypertrophic zone downward to the apex and apical phenotype is without a pressure gradient in the LVOT.
The morphology, nature of hemodynamic abnormalities not well studied in patients with apical phenotype of HCM, and surgical treatment are controversial, and for those patients with advanced stage of the HF the orthotopic heart transplantations (HTx) is usually considered.
One of the surgical techniques available for this category of patients is apical myectomy. The main goal of this intervention is increasing the left ventricular volume and improving of the LV compliance with an increase of the diastolic relaxation. Limited data of such procedures in HCM patients were already published but it still requires further investigation on larger cohort of patients.
In this study, the investigators hypothesize that along with left ventricular septal hypertrophy, a small cavity is formed in patients with submittal-apical phenotype due to an increased number of hypertrophied papillary muscles. They are displaced to the apex and tightly fixed both among themselves and to the left ventricular walls. This causes a significant reduction in diastolic volume and left ventricular relaxation capacity. The present study will analyze the experience of performing resection of hypertrophied trabeculae and mobilization of papillary muscles performed through the aorta. Throw this approach procedure can be done without the need for traumatic access and suturing in the apex of the left ventricle.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hypertrophic apical cardiomyopathy undergoing surgical interventions | – | Procedure: Surgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstructionPatients who underwent surgery for apical hypertrophic cardiomyopathy without significant left ventricular outflow tract obstruction. Patients with transapical surgical access will not be included in the study. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include all patients meeting the inclusion criteria treated in the period from 2017 to 2024 at the Petrovsky National Research Centre of Surgery and the Federal Cardiac Surgery Center in Astrakhan
Key inclusion criteria (2 listed)
- Hypertrophic apical cardiomyopathy according to medical records
- Surgical left ventricular remodeling performed
Key exclusion criteria (1 listed)
- LVOT gradient greater than 30 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstructionThe proposed intervention is a variation of classical myectomy, but unlike it, the main substrate for resection is not only the hypertrophied interventricular septum, but the abnormal papillary muscles and interpapillary trabeculae in the left ventricular cavity | Procedure or surgery | Patients with hypertrophic apical cardiomyopathy undergoing surgical interventions |
Primary outcome
Hospital mortality after undergoing trans aortic surgical left ventricular remodeling
Time frame: Assessment by medical records during the first 28 days after surgical intervention
Binary value: of alive/dead
4 secondary outcomes
left ventricular diastolic dysfunction
Time frame: Perioperative/Periprocedural
Heart Failure (NYHA)
Time frame: 1 month after surgery
Need for mechanical circulation in the postoperative period
Time frame: Perioperative/Periprocedural
Freedom from re-interventions after surgical left ventricular remodeling
Time frame: hrough study completion, an average of 1 year
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 2 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Apical Hypertrophic Cardiomyopathy
Enrolling by invitationPhase 4
The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction
Hypertrophic Cardiomyopathy (HCM)
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.
Sergey L Dzemeshkevich, MD, PhD, Prof. principal investigator
Petrovsky National Research Centre of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Hypertrophic Cardiomyopathy, run by Petrovsky National Research Centre of Surgery at 1 site 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 2 inclusion and 1 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Hospital mortality after undergoing trans aortic surgical left ventricular remodeling (time frame: Assessment by medical records during the first 28 days after surgical intervention). 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 2 Jul 2025.