Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction

Remodeling, Ventricular Clinical Trial

— RASTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230551
• Other study ID #: RASTA_V6
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2021
• Source: St. Antonius Hospital
• Contact: Jurrien M ten Berg, MD PhD
• Phone: +31 88 320 1121
• Email: j.ten.berg[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• PTSMA
Alcohol Septal Ablation

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	St. Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrosis	Extracellular Volume Fraction	2 years
Primary	Global longitudinal strain (TTE)	Diastolic Function	2 years
Primary	Deformation (CMR)	Shortening Index	2 years
Primary	Haemodynamics	Left and Right-Sided Pressure Gradients (TTE)	2 years
Primary	4D velocity mapping	Blood Flow	2 years
Primary	LV Geometry	Volume	2 years
Secondary	New York Heart Association (NYHA) classification	Exercise tolerance	2 years