Hypertrophic Obstructive CardiomyopathyNCT02054221
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.
A study testing myoectomy and Mitral valve surgery in people with Hypertrophic Obstructive Cardiomyopathy, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy
- What is being tested?
- myoectomy and Mitral valve surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2013to May 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to sign Informed Consent and Release of Medical Information forms
- Age ≥ 18 years
- obstructive hypertrophic cardiomyopathy
- surgically significant mitral insufficiency
- II-IV (NYHA),
- average systolic pressure gradient greater than 50 mm Hg. Art. at rest;
- basal or medium ventricular obstruction
Who cannot join
- Related defect of the aortic valve;
- Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis);
- Surgically significant coronary artery lesions;
- Patients requiring implantation of a cardioverter-defibrillator
Trial locations and contacts
1 site in 1 country.
Russia1 site
Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, Novosibirsk Territory, 630055
About this study
Official title: Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
Read the detailed description
Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. But the question remains what is best for patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency: use extended myoectomy with mitral valve repair a or replacement.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Being tested
- myoectomy, Mitral valve surgery
- Keywords
- hypertrophic cardiomyopathy, mitral valve
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myoectomyProcedure or surgery
Also called Extended myoectomy
The scheme of Extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM.
Mitral valve surgeryProcedure or surgery
Also called mitral valve replacement
41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.
Mitral valve surgeryProcedure or surgery
Also called mitral valve repair
41 patients will be performed mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group.
| Study group | Role | What they receive |
|---|---|---|
| extended myectomy + MVreplacement | Other | Procedure: extended myoectomy, mitral valve surgery
Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy with full isscheniem subvalvular apparatus and mitral valve replacement.
Evaluation results will be made myoectomy as TEE and direct tensiometer. Receives: Procedure: myoectomy; Procedure: Mitral valve surgery |
| extended myectomy + MVrepair | Other | Procedure: extended myoectomy, mitral valve surgery
Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy which supplemented resection and release of the papillary muscles and the mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group.
Evaluation results will be made myoectomy as TEE and direct tensiometer . Receives: Procedure: myoectomy; Procedure: Mitral valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)
Measured: one year
Secondary outcomes (1)
The pressure gradient in the output section of the left ventricle
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Aleksandr V Bogachev-Prokophiev, PhD, Principal investigator, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054221
- Sponsor's protocol ID
- HOCM - 95
- Other IDs
- 1957
- Status last verified
- Jul 2015
- First submitted
- 27 Dec 2013
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With severe Mitral regurgitation
Bogachev-Prokophiev A, Afanasyev A, Zheleznev S, Fomenko M, Sharifulin R, Kretov E, Karaskov A. Mitral valve repair or replacement in hypertrophic obstructive cardiomyopathy: a prospective randomized study. Interact Cardiovasc Thorac Surg. 2017 Sep 1;25(3):356-362. doi: 10.1093/icvts/ivx152.
PubMed 28575282
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.
- ClinicalTrials.gov ID
- NCT02054221
- Acronym / sponsor ID
- HOCM - 95
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Keywords
- hypertrophic cardiomyopathy, mitral valve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Feb 2014 (estimated)
- 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.
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
Detailed description
Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. But the question remains what is best for patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency: use extended myoectomy with mitral valve repair a or replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extended myectomy + MVreplacement | Other | Procedure: myoectomy, Procedure: Mitral valve surgeryProcedure: extended myoectomy, mitral valve surgery Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy with full isscheniem subvalvular apparatus and mitral valve replacement. Evaluation results will be made myoectomy as TEE and direct tensiometer. |
| extended myectomy + MVrepair | Other | Procedure: myoectomy, Procedure: Mitral valve surgeryProcedure: extended myoectomy, mitral valve surgery Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy which supplemented resection and release of the papillary muscles and the mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group. Evaluation results will be made myoectomy as TEE and direct tensiometer . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to sign Informed Consent and Release of Medical Information forms
- Age ≥ 18 years
- obstructive hypertrophic cardiomyopathy
- surgically significant mitral insufficiency
- II-IV (NYHA),
Key exclusion criteria (4 listed)
- Related defect of the aortic valve;
- Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis);
- Surgically significant coronary artery lesions;
- Patients requiring implantation of a cardioverter-defibrillator
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 |
|---|---|---|
| myoectomyAlso: Extended myoectomyThe scheme of Extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM. | Procedure or surgery | extended myectomy + MVrepair, extended myectomy + MVreplacement |
| Mitral valve surgeryAlso: mitral valve replacement41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus. | Procedure or surgery | extended myectomy + MVreplacement |
| Mitral valve surgeryAlso: mitral valve repair41 patients will be performed mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group. | Procedure or surgery | extended myectomy + MVrepair |
Primary outcome
The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)
Time frame: one year
1 secondary outcome
The pressure gradient in the output section of the left ventricle
Time frame: one year
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 2 Jul 2015.
- BackgroundSurgical Treatment of Hypertrophic Obstructive Cardiomyopathy With severe Mitral regurgitation
- Derived from this study: PubMed 28575282Bogachev-Prokophiev A, Afanasyev A, Zheleznev S, Fomenko M, Sharifulin R, Kretov E, Karaskov A. Mitral valve repair or replacement in hypertrophic obstructive cardiomyopathy: a prospective randomized study. Interact Cardiovasc Thorac Surg. 2017 Sep 1;25(3):356-362. doi: 10.1093/icvts/ivx152.
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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.
Aleksandr V Bogachev-Prokophiev, PhD principal investigator
Meshalkin Research Institute of Pathology of Circulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myoectomy and Mitral valve surgery in people with Hypertrophic Obstructive Cardiomyopathy, run by Meshalkin Research Institute of Pathology of Circulation 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 7 inclusion and 4 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 2 Jul 2015. 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?
The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02054221, which also lists 2 linked publications.
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 2015.