NCT03877731

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

12.5 years

First QC Date

March 11, 2019

Last Update Submit

June 23, 2026

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

hypertrophic cardiomyopathy, mitral valve, echocardiography

Outcome Measures

Primary Outcomes (1)

  • Event-free survival

    patients' survival without hospital admissions due to the recurring sympthoms

    5 years

Secondary Outcomes (4)

  • Residual left vetricular outflow tract gradient

    5 years

  • Mitral regurgitation

    5 years

  • Papillary muscles' funcion

    5 years

  • Mitral valve geometry

    10 days

Study Arms (6)

hypertrophic cariomyopathy, isolated septal myectomy

ACTIVE COMPARATOR

Patients with hypertrophic obstructive cardiomyopathy who will undergo isolated septal myectomy

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)

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)

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

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

Interventions

isolated septal myectomyPROCEDURE
hypertrophic cariomyopathy, isolated septal myectomy
septal myectomy + edge-to-edge mitral valve repairPROCEDURE
hypertrophic cariomyopathy, septal myectomy + edge-to-edge
septal myectomy + posterior leaflet sliding plastyPROCEDURE
hypertrophic cariomyopathy, septal myectomy + sliding plasty
septal myectomy + secondary chordae transectionPROCEDURE
hypertrophic cariomyopathy, septal myectomy + chordae

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology research institute, National Research Medical Center of the Russian Academy of Sciences

Tomsk, 634012, Russia

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Elena Pavlyukova, MD, PhD

    Cardiology Research Institute, Tomsk NRMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 18, 2019

Study Start

December 1, 2006

Primary Completion

May 30, 2019

Study Completion

September 1, 2019

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)