- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04329689
Hyp Obst Cardiomyopathy
Hypertrophic ObsructiveCardiomyopathy:Should the Mitral Valve be Addressed During Septal Myectomy?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypertrophic Obstructive cardiomyopathy (HOCM) is the most common genetic cardiomyopathy, heterogeneous in phenotype and clinical course. The genotype-phenotype relationship and associated molecular mechanisms are still incompletely understood. In the HOCM milieu, increased energy cost of force production, impairing performance and mitochondrial function, may be associated to patients' genotype and/or phenotype (1).
Hypertrophic cardiomyopathy as a clinical entity was first described by Brock in 1957 (2). Hypertrophic cardiomyopathy is the most common cause of sudden cardiac death in young people, including competitive athletes (3).
The characteristic pathologic features of hypertrophic cardiomyopathy are asymmetric hypertrophy, especially of the interventricular septum myocardial fiber hypertrophy and disorganisation of myocardial cells, abnormal thickened intramyocardial coronary vessels ("small vessel disease") and interstitial fibrosis (4). In the majority of patients (approximately 90%), hypertrophy mainly involves the interventricular septum and anterolateral wall. In a minority of patients myocardial hypertrophy is confined to the apical part of the left ventricle (4).
Myocardial hypertrophy is not the only hallmark of hypertrophic Obsructive cardiomyopathy. Klues et al. have described anatomic alterations in the mitral apparatus which may be present in this disorder: an increase of the mitral valve area, increase in length of the anterior leaflet, abnormal laxity and anterior displacement of the valve (5). Mitral valve (MV) leaflets have an important role in the pathophysiological process of left ventricular (LV) outflow tract obstruction in patients with hypertrophic obstructive cardiomyopathy (HOCM). Systolic anterior motion (SAM) of the mitral apparatus and contact of the leaflets with the hypertrophied septum narrow the LV outflow, leading to dynamic pressure gradients and in many patients, mitral regurgitation (MR) (6).
Currently, surgery is the gold standard treatment for most drug refractory and severely symptomatic patients [New York Heart Association (NYHA) class III or IV] with obstructive HOCM [7].
The Septal myectomy is the preferred treatment of most patients with HOCM, and many studies have documented relief of symptoms and satisfactory late patient survival after relief of outflow tract gradients.
valve repair or replacement may be necessary (7). However, adequate septal myectomy relieves outflow tract gradients, SAM of the MV, and MR in many patients (6). Nevertheless, several reports have described adjunctive techniques of mitral valvuloplasty aimed at eliminating SAM of the MV (8,9).
Guidelines support decisions to select surgery for patients with mitral structural abnormalities. The 2011 American guidelines state: "Additionally, specific abnormalities of the mitral valve and its support apparatus can contribute significantly to the generation of outflow tract obstruction, suggesting the potential value of additional surgical approaches (e.g., plication, valvuloplasty, and papillary muscle relocation) and making myectomy more appropriate than alcohol septal ablation in some patients" (10)
Finally, An appreciation of mitral abnormalities in HCM has accumulated over the past 20 years (11). There has been a natural response by surgeons to this greater understanding of the contribution of mitral pathology to SAM. At myectomy, they have tried to avoid leaving unrepaired pathology by repairing the mitral valve (12).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients that present with hypertrophic obstructive cardiomyopathy (HOCM) with mean pressure gradient>50 mm Hg at rest or on provocation
- HOCM patients with severe mitral regurgitation.
- HOCM patients with New York Heart Association (NYHA) functional class II to IV despite optimal medical treatment consisting of -blocking agents, calcium channel blockers, or both.
Exclusion Criteria:
b. Exclusion criteria:
- Non-obstructive physiological characteristics.
- Previous MV surgery.
- Patient with intrinsic pathology of the mitral valve.
- Patients <18 years.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: septal myectomy alone versus septal myectomy
The aims of the present study is to:
|
The Septal myectomy is the preferred treatment of most patients with HOCM, and many studies have documented relief of symptoms and satisfactory late patient survival after relief of outflow tract gradients. valve repair or replacement may be necessary |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LVOT obstruction degree in cm by Echocardiography
Time Frame: 3 months
|
The degree of the LVOT obstruction as measured in cm by echocardiography .
|
3 months
|
Systolic anterior motion of mitral valve
Time Frame: 3 months
|
The presence of systolic anterior motion of mitral valve as assessed by post-operative echocardiography.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-Operative complictions
Time Frame: 3 months
|
Post-operative assessment by echocardiography for complications such as mitral regurgitation.
|
3 months
|
post-operative general condition
Time Frame: 3 Months
|
Assessment of post-operative general condition in terms of NYHA Classification.
|
3 Months
|
Post-operative mortality
Time Frame: 3 months
|
assessment of post-operative mortality rate
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHosp
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertrophic Obstructive Cardiomyopathy
-
French Cardiology SocietyCompleted1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy | 2- Obstructive Hypertrophic Cardiomyopathy | 3- Non Obstructive Hypertrophic CardiomyopathyFrance
-
University of Sao PauloCompletedNon-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyBrazil
-
Bristol-Myers SquibbActive, not recruitingHypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyDenmark, United States, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
-
SuZhou Sinus Medical Technologies Co.,LtdNot yet recruiting
-
Bristol-Myers SquibbActive, not recruitingHOCM, Hypertrophic Obstructive CardiomyopathyUnited States
-
Shaare Zedek Medical CenterMedtronicUnknownHOCM, Hypertrophic Obstructive Cardiomyopathy
-
Hospital Clinic of BarcelonaUnknownHypertrophic Obstructive Cardiomyopathy (HOCM)Spain
-
Michele De BonisCompletedObstructive Hypertrophic Cardiomyopathy | Septal HypertrophyItaly
-
Montreal Heart InstituteCanadian Institutes of Health Research (CIHR)Enrolling by invitationCardiomyopathies | Hypertrophic Cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Familial Hypertrophic CardiomyopathyCanada
-
Hangzhou Valgen Medtech Co., LtdNot yet recruitingObstructive Hypertrophic CardiomyopathyChina
Clinical Trials on The Septal myectom
-
Xiang WeiFudan University; Guangdong Provincial People's Hospital; Beijing Anzhen Hospital and other collaboratorsRecruitingHypertrophic Obstructive CardiomyopathyChina
-
Xiang WeiRecruitingNonobstructive Hypertrophic CardiomyopathyChina
-
Xiang WeiRecruitingHypertrophic Obstructive CardiomyopathyChina
-
Abbott Medical DevicesTerminatedAtrial Septal Defect SecundumUnited States
-
Tomsk National Research Medical Center of the Russian...CompletedHypertrophic Obstructive CardiomyopathyRussian Federation
-
University of AlbertaCompleted
-
Aarhus University Hospital SkejbyDanish Heart FoundationCompletedAtrioventricular BlockDenmark
-
University of Sao PauloW.L.Gore & Associates; InCor Heart InstituteTerminatedAcquired Tracheo-esophageal FistulaBrazil
-
Tongji HospitalWuhan Greenrhythm Medical Technology Co., LTDRecruitingAtrial FibrillationChina
-
atHeart MedicalActive, not recruitingAtrial Septal Defect | Patent Foramen OvaleGermany