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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PTSMA
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HOCM, Hypertrophic Obstructive Cardiomyopathy focused on measuring 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

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Antonius Hospital
  • St. Antonius HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Reference Group

Study Group

Observation Group

Arm Description

Five symptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA

Five asymptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA

Five asymptomatic HOCM patients with severe LVOT obstruction will not undergo PTSMA

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

New York Heart Association (NYHA) classification
Exercise tolerance

Full Information

First Posted
December 31, 2019
Last Updated
September 8, 2021
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04230551
Brief Title
Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction
Acronym
RASTA
Official Title
Reverse Remodeling After PTSMA in Severe But ASympTomAtic LVOT Obstruction (RASTA Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Symptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (reference group) Asymptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (study group) Asymptomatic HOCM patients with severe LVOT obstruction with no intervention (observation group)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Technicians and/or imaging cardiologists involved in image analysis will not be informed about the procedure in order to have an unbiased analysis at baseline. At follow-up, treated patients will have akinetic/infarcted proximal septum that will be noticed during image acquisition. However, the pre-PTSMA status (symptomatic vs. asymptomatic) will be blinded for the analysis.
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reference Group
Arm Type
Active Comparator
Arm Description
Five symptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Five asymptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA
Arm Title
Observation Group
Arm Type
No Intervention
Arm Description
Five asymptomatic HOCM patients with severe LVOT obstruction will not undergo PTSMA
Intervention Type
Procedure
Intervention Name(s)
PTSMA
Other Intervention Name(s)
Alcohol Septal Ablation
Intervention Description
Alcohol Septal Ablation
Primary Outcome Measure Information:
Title
Fibrosis
Description
Extracellular Volume Fraction
Time Frame
2 years
Title
Global longitudinal strain (TTE)
Description
Diastolic Function
Time Frame
2 years
Title
Deformation (CMR)
Description
Shortening Index
Time Frame
2 years
Title
Haemodynamics
Description
Left and Right-Sided Pressure Gradients (TTE)
Time Frame
2 years
Title
4D velocity mapping
Description
Blood Flow
Time Frame
2 years
Title
LV Geometry
Description
Volume
Time Frame
2 years
Secondary Outcome Measure Information:
Title
New York Heart Association (NYHA) classification
Description
Exercise tolerance
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jurrien M ten Berg, MD PhD
Phone
+31 88 320 1121
Email
j.ten.berg@antoniusziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jurrien M ten Berg, MD PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatih Arslan, MD PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435CM
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jurrien M ten Berg, MD PhD
Phone
+31 88 320 1121
Email
j.ten.berg@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Fatih Arslan, MD PhD
Email
f.arslan@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Fatih Arslan, MD PhD
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jurrien ten berg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32808736
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.
Results Reference
derived

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Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction

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