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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HOCM, Hypertrophic Obstructive Cardiomyopathy; LVOTO - Left Ventricular Outflow Tract Obstruction; Remodeling, Ventricular
• Intervention / Treatment: Procedure: PTSMA

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jurrien M ten Berg, MD PhD; Phone Number: +31 88 320 1121; Email: j.ten.berg@antoniusziekenhuis.nl

Study Locations

• Netherlands
  • Nieuwegein, Netherlands
    • Recruiting
    • St. Antonius Hospital
    • Contact: Jurrien ten berg
  • Nieuwegein, Netherlands, 3435CM
    • Not yet recruiting
    • St. Antonius Hospital
    • Contact: Jurrien M ten Berg, MD PhD; Phone Number: +31 88 320 1121; Email: j.ten.berg@antoniusziekenhuis.nl
    • Contact: Fatih Arslan, MD PhD; Email: f.arslan@antoniusziekenhuis.nl
    • Principal Investigator: Fatih Arslan, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Investigators: Principal Investigator: Jurriën M ten Berg, MD PhD, St. Antonius Hospital; Principal Investigator: Fatih Arslan, MD PhD, St. Antonius Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Extracellular Volume Fraction; HOCM; Hypertrophic Obstructive Cardiomyopathy; Global Longitudinal Strain; Left Ventricular Outflow Tract Obstruction; Adverse Remodeling; Reverse Remodeling; Alcohol Septal Ablation; Percutaneous Transluminal Septal Myocardial Ablation; PTSMA; Deformation Imaging; 4D Velocity Mapping
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Ventricular Remodeling
• Other Study ID Numbers: RASTA_V6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No