Clinical trial NCT06977646: Surgical Treatment of the Patients With Restrictive Phenotype of the Hypertrophic Cardiomyopathy Without LVOT Obstruction
Official title: Retrospective Study of the Surgical Treatment Restrictive Form of the Hypertrophic Cardiomyopathy Without of the Left Ventricular Outflow Tract Obstruction
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Apical Hypertrophic Cardiomyopathy
Keywords: Apical hypertrophic cardiomyopathy
Midventricular obstruction and cavity obliteration
Septal myectomy
hypertrophic cardiomyopathy
sudden cardiac death
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Hypertrophic apical cardiomyopathy according to medical records
* Surgical left ventricular remodeling performed

Exclusion Criteria:

* LVOT gradient greater than 30 mmHg

Primary outcomes:
measure: Hospital mortality after undergoing trans aortic surgical left ventricular remodeling
timeFrame: Assessment by medical records during the first 28 days after surgical intervention
Secondary outcomes:
measure: left ventricular diastolic dysfunction
timeFrame: Perioperative/Periprocedural
measure: Heart Failure (NYHA)
timeFrame: 1 month after surgery
measure: Need for mechanical circulation in the postoperative period
timeFrame: Perioperative/Periprocedural
measure: Freedom from re-interventions after surgical left ventricular remodeling
timeFrame: hrough study completion, an average of 1 year
Other outcomes:
measure: Search for mutations in full genomic DNA by sequencing method
timeFrame: through study completion, an average of 1 year
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky National Research Centre of Surgery
Study officials:
affiliation: Petrovsky National Research Centre of Surgery
name: Sergey L Dzemeshkevich, MD, PhD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: