Clinical trial NCT04230551: Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction
Official title: Reverse Remodeling After PTSMA in Severe But ASympTomAtic LVOT Obstruction (RASTA Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HOCM, Hypertrophic Obstructive Cardiomyopathy
LVOTO - Left Ventricular Outflow Tract Obstruction
Remodeling, Ventricular
Keywords: 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
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Fibrosis
timeFrame: 2 years
measure: Global longitudinal strain (TTE)
timeFrame: 2 years
measure: Deformation (CMR)
timeFrame: 2 years
measure: Haemodynamics
timeFrame: 2 years
measure: 4D velocity mapping
timeFrame: 2 years
measure: LV Geometry
timeFrame: 2 years
Secondary outcomes:
measure: New York Heart Association (NYHA) classification
timeFrame: 2 years
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: St. Antonius Hospital
name: Jurrien M ten Berg, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Fatih Arslan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arslan F, Akdim F, Ten Berg JM. Reverse remodeling after percutaneous transluminal septal myocardial ablation in severe but asymptomatic LVOT obstruction (RASTA) study: Rationale and design of transcatheter septal reduction in asymptomatic patients with severe hypertrophic obstructive cardiomyopathy. Catheter Cardiovasc Interv. 2021 Feb 15;97(3):488-492. doi: 10.1002/ccd.29178. Epub 2020 Aug 18.