## Protocol Section
### Identification Module
**NCT ID:** NCT03524079

**Acronym:** RV-BrS

**Brief Title:** Right Ventricle Morphology and Hemodynamics in BrS

**Official Title:** Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome

#### Organization Study ID Info
**ID:** RV & BrS
#### Organization
**Class:** OTHER
**Full Name:** IRCCS Policlinico S. Donato
### Status Module
#### Completion Date
**Date:** 2019-11-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-05-18

**Type:** ACTUAL

**Last Update Submit Date:** 2021-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-11-08

**Type:** ACTUAL

#### Start Date
**Date:** 2018-04-19

**Type:** ACTUAL

**Status Verified Date:** 2021-05

#### Study First Post Date
**Date:** 2018-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2018-04-19
**Study First Submit QC Date:** 2018-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** IRCCS Policlinico S. Donato

#### Responsible Party

**Investigator Affiliation:** IRCCS Policlinico S. Donato

**Investigator Full Name:** Carlo Pappone

**Investigator Title:** Head of Arrhythmology Department

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Brugada Syndrome

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Ajmaline 17-(Chloroacetate) Monohydrochloride

**Intervention Names:**

- Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride

**Label:** BrS Group

#### Arm Group 2

**Description:** Ajmaline 17-(Chloroacetate) Monohydrochloride

**Intervention Names:**

- Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride

**Label:** No BrS group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BrS Group

- No BrS group

**Description:** Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)

**Name:** Ajmaline 17-(Chloroacetate) Monohydrochloride

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Changes of PR, QRS, and QT parameters, before and after ajmaline in Brugada patients as compared with control subjects

**Measure:** Electrocardiographic changes

**Time Frame:** 1 day during Electrocardiography

**Description:** MRI changes of left and right ventricular function before and after ajmaline in Brugada patients as compared with control subjects

**Measure:** MRI changes of left and right ventricular function

**Time Frame:** 1day during MRI

**Description:** Changes of right ventricular areal strain before and after ajmaline in Brugada patients as compared with controls

**Measure:** CMR parameters changes of the right and left ventricle function

**Time Frame:** 1 day during CMR

**Description:** electroanatomical epicardial mapping for substrate determination before and after ajmaline

**Measure:** Electrical substrate changes of the right ventricle

**Time Frame:** 1 day after ICD implantation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnancy
* Contraindication to CMRI or to ajmaline
* Live espectance \< 12 months

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** A total of 60 selected subjects (30 BrS patients and 30 normal controls) will be enrolled.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Donato Milanese

**Country:** Italy

**Facility:** IRCCS Policlinico S. Donato

**State:** Milano

**Zip:** 20097

#### Overall Officials

**Official 1:**

**Affiliation:** IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy

**Name:** Carlo Pappone, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 34693720

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000075224

- Term: Cardiac Conduction System Disease

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M27508

- Name: Brugada Syndrome

- Relevance: HIGH

- As Found: Brugada Syndrome

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M1472

- Name: Cardiac Conduction System Disease

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: T882

- Name: Brugada Syndrome

- Relevance: HIGH

- As Found: Brugada Syndrome

### Condition Browse Module - Meshes

- ID: D000053840

- Term: Brugada Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Ancestors

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000061567

- Term: Voltage-Gated Sodium Channel Blockers

- ID: D000026941

- Term: Sodium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M3752

- Name: Ajmaline

- Relevance: HIGH

- As Found: Myxoid

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M23177

- Name: Sodium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M30025

- Name: Diuretics, Potassium Sparing

- Relevance: LOW

- As Found: Unknown

- ID: T357

- Name: Ajmaline

- Relevance: HIGH

- As Found: Myxoid

### Intervention Browse Module - Meshes

- ID: D000000404

- Term: Ajmaline

### Misc Info Module

- Version Holder: 2024-05-24
