Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction

Study Overview
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Brief Summary
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Patients with HOCM and severe LVOT obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders. Hence, preventing adverse remodeling through LVOT desobstruction may have significant impact on cardiac function and geometry in this particular population, as it is in symptomatic patients. The investigators will assess functional and structural characteristics of the myocardium in asymptomatic vs. symptomatic patients with severe LVOT obstruction before and after PTSMA, using advanced imaging studies with LGE-CMR and echocardiography.

Detailed Description
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The trial consists of three cohorts Symptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (reference group) Asymptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (study group) Asymptomatic HOCM patients with severe LVOT obstruction with no intervention (observation group)

Official Title
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Reverse Remodeling After PTSMA in Severe But ASympTomAtic LVOT Obstruction (RASTA Study)

Conditions
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HOCM, Hypertrophic Obstructive Cardiomyopathy, LVOTO - Left Ventricular Outflow Tract Obstruction, Remodeling, Ventricular

Intervention / Treatment
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* Procedure: PTSMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 40 yrs HOCM diagnosed by experienced cardiologists (European Society of Cardiology (ESC)-certified imaging cardiologists and/or finalized fellowship imaging) LVOT obstruction >30 mmHg pressure gradient in rest, or >50 mmHg during exercise by TTE and/or invasive measurement, performed experienced (imaging) cardiologists Symptomatic (NYHA class >2 or CCS class >2) Asymptomatic: free of any dyspnea/chest pain or discomfort associated with LVOT obstruction Exclusion Criteria: LV wall thickness <15 mm Other conditions responsible for hypertrophy (e.g. hypertension, aortic valve disease) Moderate to severe mitral valve regurgitation Systolic anterior motion of the mitral valve Coronary artery disease requiring intervention Pregnancy

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference Group<br>Five symptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA | Procedure: PTSMA<br>* Alcohol Septal Ablation<br>* Other names: Alcohol Septal Ablation;|
| Experimental: Study Group<br>Five asymptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA | Procedure: PTSMA<br>* Alcohol Septal Ablation<br>* Other names: Alcohol Septal Ablation;|
| No Intervention: Observation Group<br>Five asymptomatic HOCM patients with severe LVOT obstruction will not undergo PTSMA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrosis | Extracellular Volume Fraction | 2 years | 
| Global longitudinal strain (TTE) | Diastolic Function | 2 years | 
| Deformation (CMR) | Shortening Index | 2 years | 
| Haemodynamics | Left and Right-Sided Pressure Gradients (TTE) | 2 years | 
| 4D velocity mapping | Blood Flow | 2 years | 
| LV Geometry | Volume | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New York Heart Association (NYHA) classification | Exercise tolerance | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HOCM, Hypertrophic Obstructive Cardiomyopathy, Left Ventricular Outflow Tract Obstruction, Adverse Remodeling, Reverse Remodeling, Alcohol Septal Ablation, Percutaneous Transluminal Septal Myocardial Ablation, PTSMA, Extracellular Volume Fraction, Global Longitudinal Strain, Deformation Imaging, 4D Velocity Mapping