Hypertrophic Obstructive CardiomyopathyNCT03877731
Mitral Valve in Hypertrophic Cardiomyopathy
A study testing isolated septal myectomy, septal myectomy + edge-to-edge mitral valve repair and septal myectomy + posterior leaflet sliding plasty in people with Hypertrophic Obstructive Cardiomyopathy, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
The purpose of the study is to assess the role of mitral valve apparatus in the development of outflow tract obstruction in patients with hypertrophic cardiomyopathy and to identify the best surgical treatment modality to relieve outflow tract obstruction in such patients Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy
- What is being tested?
- isolated septal myectomy, septal myectomy + edge-to-edge mitral valve repair and septal myectomy + posterior leaflet sliding plasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2006to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Signed informed consent to participate in the study
- For patients with hypertrophic cardiomyopathy only: resting or latent peak left ventricular outflow tract gradient >50 mmHg, NYHA class III-IV
- For patients with arterial hypertension only: hystory of arterial pressure increase >140/90 mmHg, increased left vantricular wall thickness (>10 mm) and myocardial mass indexed to BSA (>95 g/m2 for women and >115 g/m2 for men), as assessed by 2D transthoracic echocardiography
Who cannot join
- Age < 18 years
- Persistent form of atrial fibrillation
- Intrinsic mitral or aortic valve disease
- Coronary artery disease
- Reduced left ventricular ejection fraction
- For control group only: presence of any structural heart disease
Trial locations and contacts
1 site in 1 country.
Russia1 site
Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences
Tomsk, 634012
About this study
Official title: Role of Mitral Valve in the Obstruction of Left Ventricular Outflow Tract in Patients With Hypertrophic Cardiomyopathy
The purpose of the study is to assess the role of mitral valve apparatus in the development of outflow tract obstruction in patients with hypertrophic cardiomyopathy and to identify the best surgical treatment modality to relieve outflow tract obstruction in such patients
Read the detailed description
It is well-known that mitral valve plays an important role in the development of left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. In order to further investigate this phenomenon, the following study aims to compare mitral valve geometry indices, as assessed by transthoracic echocardiography, two- and three-dimentional transesophageal echocardiography and mitral valve quantification analysis, and papillary musles' function, as assessed by 2D speckle tracking imaging, in patients with hypertrophic obstructive cardiomyopathy, patients with arterial hypertension and left ventricular hypertrophy and people without structural heart disease. This will provide information on the geometric characteristics of mitral valve that predispose to the development of obstruction. Futhermore, patients with hypertrophic obstructive cardiomyopathy that are eligible for the surgical relief of obstruction will be randomised into four groups according to the modality of intervention. These groups are as follows: 1) isolated extended septal myectomy; 2) extended septal myectomy + edge to edge mitral valve repair; 3) extended septal myectomy + posterior lealfet sliding plasty; 4) extended septal myectomy + secondary chordae transection. After surgery, said indices will be reassessed and the degree of outflow tract obstruction relief noted, in order to elicit which geometrical changes are produced by each type of intervention. Patients will be followed long-term, up to 5 years, in order to define whether the addition of the intervention on mitral valve helps abolish the residual gradient more effectively, and whether it translates into any survival benefit.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Being tested
- isolated septal myectomy, septal myectomy + edge-to-edge mitral valve repair, septal myectomy + posterior leaflet sliding plasty, septal myectomy + secondary chordae transection
- Keywords
- hypertrophic cardiomyopathy, mitral valve, echocardiography
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isolated septal myectomyProcedure or surgery
septal myectomy + edge-to-edge mitral valve repairProcedure or surgery
septal myectomy + posterior leaflet sliding plastyProcedure or surgery
septal myectomy + secondary chordae transectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| hypertrophic cariomyopathy, isolated septal myectomy | Active comparator | Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy Receives: Procedure: isolated septal myectomy |
| hypertrophic cariomyopathy, septal myectomy + edge-to-edge | Experimental | Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and edge-to-edge mitral valve repair (O. Alfieri technique) Receives: Procedure: septal myectomy + edge-to-edge mitral valve repair |
| hypertrophic cariomyopathy, septal myectomy + sliding plasty | Experimental | Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique) Receives: Procedure: septal myectomy + posterior leaflet sliding plasty |
| hypertrophic cariomyopathy, septal myectomy + chordae | Experimental | Patients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection Receives: Procedure: septal myectomy + secondary chordae transection |
| Arterial hypertension + left ventricular hypertrophy | No intervention | Patients with arterial hypertension with left ventricular hypertrophy whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy |
| Control | No intervention | Patients without structural heart disease whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
patients' survival without hospital admissions due to the recurring sympthoms
Measured: 5 years
Secondary outcomes (4)
Residual left vetricular outflow tract gradient
left ventricular outflow tract gradient measured by continuous doppler from 5-chamber apical view
Measured: 5 years
Mitral regurgitation
degree of mitral regurgitation assessed by color doppler, regurgitant volume measured using PISA method
Measured: 5 years
Papillary muscles' funcion
papillary muscles' strain and strain rate assessed by 2D speckle tracking imaging
Measured: 5 years
Mitral valve geometry
indices of mitral valve geometry assessed by 2D transthoracic and transesophageal echocardiography and mitral valve quantification analysis
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Dec 2006
- Primary completion30 May 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Obstructive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Pavlyukova, MD, PhD, Principal investigator, Cardiology Research Institute, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877731
- Sponsor's protocol ID
- CRI-151
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2019
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mitral Valve in the Obstruction of Left Ventricular Outflow Tract in Patients With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03877731
- Acronym / sponsor ID
- CRI-151
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Keywords
- hypertrophic cardiomyopathy, mitral valve, echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 1 Dec 2006 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 18 Mar 2019 (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.
The purpose of the study is to assess the role of mitral valve apparatus in the development of outflow tract obstruction in patients with hypertrophic cardiomyopathy and to identify the best surgical treatment modality to relieve outflow tract obstruction in such patients
Detailed description
It is well-known that mitral valve plays an important role in the development of left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. In order to further investigate this phenomenon, the following study aims to compare mitral valve geometry indices, as assessed by transthoracic echocardiography, two- and three-dimentional transesophageal echocardiography and mitral valve quantification analysis, and papillary musles' function, as assessed by 2D speckle tracking imaging, in patients with hypertrophic obstructive cardiomyopathy, patients with arterial hypertension and left ventricular hypertrophy and people without structural heart disease. This will provide information on the geometric characteristics of mitral valve that predispose to the development of obstruction. Futhermore, patients with hypertrophic obstructive cardiomyopathy that are eligible for the surgical relief of obstruction will be randomised into four groups according to the modality of intervention. These groups are as follows: 1) isolated extended septal myectomy; 2) extended septal myectomy + edge to edge mitral valve repair; 3) extended septal myectomy + posterior lealfet sliding plasty; 4) extended septal myectomy + secondary chordae transection. After surgery, said indices will be reassessed and the degree of outflow tract obstruction relief noted, in order to elicit which geometrical changes are produced by each type of intervention. Patients will be followed long-term, up to 5 years, in order to define whether the addition of the intervention on mitral valve helps abolish the residual gradient more effectively, and whether it translates into any survival benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| hypertrophic cariomyopathy, isolated septal myectomy | Active comparator | Procedure: isolated septal myectomyPatients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy |
| hypertrophic cariomyopathy, septal myectomy + edge-to-edge | Experimental | Procedure: septal myectomy + edge-to-edge mitral valve repairPatients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and edge-to-edge mitral valve repair (O. Alfieri technique) |
| hypertrophic cariomyopathy, septal myectomy + sliding plasty | Experimental | Procedure: septal myectomy + posterior leaflet sliding plastyPatients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and posterior leaflet sliding plasty ( A. Carpentier technique) |
| hypertrophic cariomyopathy, septal myectomy + chordae | Experimental | Procedure: septal myectomy + secondary chordae transectionPatients with hypertrophic obstructive cardiomyopathy who will undergo septal myectomy and secondary chordae transection |
| Arterial hypertension + left ventricular hypertrophy | No intervention | –Patients with arterial hypertension with left ventricular hypertrophy whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy |
| Control | No intervention | –Patients without structural heart disease whose mitral valve geometry and papillary muscles' function will be compared to those of the patients with hypertrophic cardiomyopathy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Signed informed consent to participate in the study
- For patients with hypertrophic cardiomyopathy only: resting or latent peak left ventricular outflow tract gradient >50 mmHg, NYHA class III-IV
- For patients with arterial hypertension only: hystory of arterial pressure increase >140/90 mmHg, increased left vantricular wall thickness (>10 mm) and myocardial mass indexed to BSA (>95 g/m2 for women and >115 g/m2 for men), as assessed by 2D transthoracic echocardiography
Key exclusion criteria (6 listed)
- Age < 18 years
- Persistent form of atrial fibrillation
- Intrinsic mitral or aortic valve disease
- Coronary artery disease
- Reduced left ventricular ejection fraction
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 |
|---|---|---|
| isolated septal myectomy | Procedure or surgery | hypertrophic cariomyopathy, isolated septal myectomy |
| septal myectomy + edge-to-edge mitral valve repair | Procedure or surgery | hypertrophic cariomyopathy, septal myectomy + edge-to-edge |
| septal myectomy + posterior leaflet sliding plasty | Procedure or surgery | hypertrophic cariomyopathy, septal myectomy + sliding plasty |
| septal myectomy + secondary chordae transection | Procedure or surgery | hypertrophic cariomyopathy, septal myectomy + chordae |
Primary outcome
Event-free survival
Time frame: 5 years
patients' survival without hospital admissions due to the recurring sympthoms
4 secondary outcomes
Residual left vetricular outflow tract gradient
Time frame: 5 years
Mitral regurgitation
Time frame: 5 years
Papillary muscles' funcion
Time frame: 5 years
Mitral valve geometry
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- 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. This study is not recruiting at the moment.
Elena Pavlyukova, MD, PhD principal investigator
Cardiology Research Institute, Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isolated septal myectomy, septal myectomy + edge-to-edge mitral valve repair and septal myectomy + posterior leaflet sliding plasty in people with Hypertrophic Obstructive Cardiomyopathy, run by Tomsk National Research Medical Center of the Russian Academy of Sciences 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Event-free survival (time frame: 5 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 26 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.