Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction — RASTA  

Remodeling, Ventricular Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The trial consists of three cohorts

1. Symptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (reference group)

2. Asymptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (study group)

3. Asymptomatic HOCM patients with severe LVOT obstruction with no intervention (observation group) ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• HOCM, Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy
• LVOTO - Left Ventricular Outflow Tract Obstruction
• Remodeling, Ventricular
• Ventricular Remodeling

• NCT number: NCT04230551
• Study type: Interventional
• Source: St. Antonius Hospital
• Contact: Jurrien M ten Berg, MD PhD
• Phone: +31 88 320 1121
• Email: j.ten.berg@antoniusziekenhuis.nl
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2020
• Completion date: January 1, 2024