HOCM, Hypertrophic Obstructive CardiomyopathyRASTANCT04230551
Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction
A study testing PTSMA in people with HOCM, Hypertrophic Obstructive Cardiomyopathy and LVOTO - Left Ventricular Outflow Tract Obstruction, run by St. Antonius Hospital at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HOCM, Hypertrophic Obstructive Cardiomyopathy, LVOTO - Left Ventricular Outflow Tract Obstruction, Remodeling, Ventricular
- What is being tested?
- PTSMA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesNetherlands
- Study dates
- 21 Jan 2020to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
St. Antonius Hospital
Nieuwegein, 3435CM
Jurrien M ten Berg, MD PhD, +31 88 320 1121, j.ten.berg@antoniusziekenhuis.nl
Fatih Arslan, MD PhD, f.arslan@antoniusziekenhuis.nl
- Recruiting
St. Antonius Hospital
Nieuwegein
Jurrien ten berg
About this study
Official title: 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.
Read the 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)
- Conditions
- HOCM, Hypertrophic Obstructive Cardiomyopathy, LVOTO - Left Ventricular Outflow Tract Obstruction, Remodeling, Ventricular
- Being tested
- PTSMA
- 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
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Ventricular Outflow Obstruction, Left, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSMAProcedure or surgery
Also called Alcohol Septal Ablation
Alcohol Septal Ablation
| Study group | Role | What they receive |
|---|---|---|
| Reference Group | Active comparator | Five symptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA Receives: Procedure: PTSMA |
| Study Group | Experimental | Five asymptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA Receives: Procedure: PTSMA |
| Observation Group | No intervention | Five asymptomatic HOCM patients with severe LVOT obstruction will not undergo PTSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis
Extracellular Volume Fraction
Measured: 2 years
Global longitudinal strain (TTE)
Diastolic Function
Measured: 2 years
Deformation (CMR)
Shortening Index
Measured: 2 years
Haemodynamics
Left and Right-Sided Pressure Gradients (TTE)
Measured: 2 years
4D velocity mapping
Blood Flow
Measured: 2 years
LV Geometry
Volume
Measured: 2 years
Secondary outcomes (1)
New York Heart Association (NYHA) classification
Exercise tolerance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start21 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HOCM, Hypertrophic Obstructive CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.M. ten Berg, St. Antonius Hospital
- Investigators
- Jurrien M ten Berg, MD PhD, Principal investigator, St. Antonius HospitalFatih Arslan, MD PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230551
- Sponsor's protocol ID
- RASTA_V6
- Acronym
- RASTA
- Status last verified
- Sep 2021
- First submitted
- 31 Dec 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32808736
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Remodeling After PTSMA in Severe But ASympTomAtic LVOT Obstruction (RASTA Study)
- ClinicalTrials.gov ID
- NCT04230551
- Acronym / sponsor ID
- RASTA / RASTA_V6
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference Group | Active comparator | Procedure: PTSMAFive symptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA |
| Study Group | Experimental | Procedure: PTSMAFive asymptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA |
| Observation Group | No intervention | –Five asymptomatic HOCM patients with severe LVOT obstruction will not undergo PTSMA |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTSMAAlso: Alcohol Septal AblationAlcohol Septal Ablation | Procedure or surgery | Reference Group, Study Group |
Primary outcome
Fibrosis
Time frame: 2 years
Extracellular Volume Fraction
Global longitudinal strain (TTE)
Time frame: 2 years
Diastolic Function
Deformation (CMR)
Time frame: 2 years
Shortening Index
Haemodynamics
Time frame: 2 years
Left and Right-Sided Pressure Gradients (TTE)
4D velocity mapping
Time frame: 2 years
Blood Flow
LV Geometry
Time frame: 2 years
Volume
1 secondary outcome
New York Heart Association (NYHA) classification
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 32808736Arslan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jurrien M ten Berg, MD PhD principal investigator
St. Antonius Hospital
Fatih Arslan, MD PhD principal investigator
St. Antonius Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTSMA in people with HOCM, Hypertrophic Obstructive Cardiomyopathy and LVOTO - Left Ventricular Outflow Tract Obstruction, run by St. Antonius Hospital at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jurrien M ten Berg, MD PhD (+31 88 320 1121, j.ten.berg@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrosis (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04230551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.