Brugada SyndromeRV-BrSNCT03524079
Right Ventricle Morphology and Hemodynamics in BrS
An observational study of Brugada Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The study purpose is to evaluate the morphological, functional and electrophysiological characteristics of the right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome as well as to correlate CMR findings and substrate size. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brugada Syndrome
- What is being tested?
- Ajmaline 17-(Chloroacetate) Monohydrochloride
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 19 Apr 2018to 9 Nov 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 60 selected subjects (30 BrS patients and 30 normal controls) will be enrolled.
Who may be able to join
- Brugada syndrome with either spontaneous or ajmaline- induced type 1 ECG pattern
- Indication to ajmaline testing and programmed ventricular stimulation
- Age > or equal to 18 years
- Written informed consent
Who cannot join
- Pregnancy
- Contraindication to CMRI or to ajmaline
- Live espectance < 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome
The study purpose is to evaluate the morphological, functional and electrophysiological characteristics of the right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome as well as to correlate CMR findings and substrate size.
Read the detailed description
All consecutive patients with either spontaneous or ajmaline-induced BrS-ECG pattern will be screened. A total of 30 BrS patients and 30 normal age, sex and BSA matched normal controls will be selected and enrolled. Patients will perform cardiac magnetic resonance imaging to evaluate and compare morphological and functional characteristics of the 2 groups before and after ajmaline. BrS patients will also perform a standardized programmed ventricular stimulation protocol and electroanatomical mapping to determine the substrate size.
- Conditions
- Brugada Syndrome
- Being tested
- Ajmaline 17-(Chloroacetate) Monohydrochloride
- Medical subject headings
- Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ajmaline 17-(Chloroacetate) MonohydrochlorideDrug
Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)
| Study group | Role | What they receive |
|---|---|---|
| BrS Group | Ajmaline 17-(Chloroacetate) Monohydrochloride Receives: Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride | |
| No BrS group | Ajmaline 17-(Chloroacetate) Monohydrochloride Receives: Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrocardiographic changes
Changes of PR, QRS, and QT parameters, before and after ajmaline in Brugada patients as compared with control subjects
Measured: 1 day during Electrocardiography
MRI changes of left and right ventricular function
MRI changes of left and right ventricular function before and after ajmaline in Brugada patients as compared with control subjects
Measured: 1day during MRI
CMR parameters changes of the right and left ventricle function
Changes of right ventricular areal strain before and after ajmaline in Brugada patients as compared with controls
Measured: 1 day during CMR
Electrical substrate changes of the right ventricle
electroanatomical epicardial mapping for substrate determination before and after ajmaline
Measured: 1 day after ICD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start19 Apr 2018
- Primary completion8 Nov 2019
- Study completion9 Nov 2019
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 Brugada SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Pappone, IRCCS Policlinico S. Donato
- Investigators
- Carlo Pappone, MD, Principal investigator, IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524079
- Sponsor's protocol ID
- RV & BrS
- Acronym
- RV-BrS
- Status last verified
- May 2021
- First submitted
- 19 Apr 2018
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pappone C, Santinelli V, Mecarocci V, Tondi L, Ciconte G, Manguso F, Sturla F, Vicedomini G, Micaglio E, Anastasia L, Pica S, Camporeale A, Lombardi M. Brugada Syndrome: New Insights From Cardiac Magnetic Resonance and Electroanatomical Imaging. Circ Arrhythm Electrophysiol. 2021 Nov;14(11):e010004. doi: 10.1161/CIRCEP.121.010004. Epub 2021 Oct 25.
PubMed 34693720
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome
- ClinicalTrials.gov ID
- NCT03524079
- Acronym / sponsor ID
- RV-BrS / RV & BrS
- Conditions
- Brugada Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 9 Nov 2019 (actual)
- First posted
- 14 May 2018 (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.
The study purpose is to evaluate the morphological, functional and electrophysiological characteristics of the right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome as well as to correlate CMR findings and substrate size.
Detailed description
All consecutive patients with either spontaneous or ajmaline-induced BrS-ECG pattern will be screened. A total of 30 BrS patients and 30 normal age, sex and BSA matched normal controls will be selected and enrolled. Patients will perform cardiac magnetic resonance imaging to evaluate and compare morphological and functional characteristics of the 2 groups before and after ajmaline. BrS patients will also perform a standardized programmed ventricular stimulation protocol and electroanatomical mapping to determine the substrate size.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BrS Group | – | Drug: Ajmaline 17-(Chloroacetate) MonohydrochlorideAjmaline 17-(Chloroacetate) Monohydrochloride |
| No BrS group | – | Drug: Ajmaline 17-(Chloroacetate) MonohydrochlorideAjmaline 17-(Chloroacetate) Monohydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 60 selected subjects (30 BrS patients and 30 normal controls) will be enrolled.
Key inclusion criteria (4 listed)
- Brugada syndrome with either spontaneous or ajmaline- induced type 1 ECG pattern
- Indication to ajmaline testing and programmed ventricular stimulation
- Age > or equal to 18 years
- Written informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Contraindication to CMRI or to ajmaline
- Live espectance < 12 months
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 |
|---|---|---|
| Ajmaline 17-(Chloroacetate) MonohydrochlorideAjmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes) | Drug | BrS Group, No BrS group |
Primary outcome
Electrocardiographic changes
Time frame: 1 day during Electrocardiography
Changes of PR, QRS, and QT parameters, before and after ajmaline in Brugada patients as compared with control subjects
MRI changes of left and right ventricular function
Time frame: 1day during MRI
MRI changes of left and right ventricular function before and after ajmaline in Brugada patients as compared with control subjects
CMR parameters changes of the right and left ventricle function
Time frame: 1 day during CMR
Changes of right ventricular areal strain before and after ajmaline in Brugada patients as compared with controls
Electrical substrate changes of the right ventricle
Time frame: 1 day after ICD implantation
electroanatomical epicardial mapping for substrate determination before and after ajmaline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 34693720Pappone C, Santinelli V, Mecarocci V, Tondi L, Ciconte G, Manguso F, Sturla F, Vicedomini G, Micaglio E, Anastasia L, Pica S, Camporeale A, Lombardi M. Brugada Syndrome: New Insights From Cardiac Magnetic Resonance and Electroanatomical Imaging. Circ Arrhythm Electrophysiol. 2021 Nov;14(11):e010004. doi: 10.1161/CIRCEP.121.010004. Epub 2021 Oct 25.
- 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.
Carlo Pappone, MD principal investigator
IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrocardiographic changes (time frame: 1 day during Electrocardiography). The study lists 4 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 NCT03524079, 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 18 May 2021.