Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction

Not Applicable

• Conditions: Remodeling, Ventricular; HOCM, Hypertrophic Obstructive Cardiomyopathy; LVOTO - Left Ventricular Outflow Tract Obstruction
• Interventions: Procedure: PTSMA

• Registration Number: NCT04230551
• Lead Sponsor: St. Antonius Hospital

Brief 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.

Detailed 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)

Study Timeline

• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-01-21
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	PTSMA	Five asymptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA
Reference Group	PTSMA	Five symptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
New York Heart Association (NYHA) classification	2 years	Exercise tolerance

Trial Locations

Locations (1)

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands