The Response To Ajmaline Provocation in Healthy Subjects

NCT02933437 | Unknown Phase 2

• 2 other identifiers: 16.00122016-004277-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Standard, high lead and sodium channel provoked electrocardiograms of a healthy volunteers will be performed to observe the various ECG changes. Participants will the undergo detailed imaging with cardiac magnetic resonance imaging and deep genotyping to identify structural or genetic variants which might dictate the electrocardiographic patterns at rest and with sodium channel provocation.

Conditions

Brugada Syndrome; Sudden Death

Keywords

Brugada syndrome; SCN5A; SCN10A; Ajmaline

Outcome Measures

Primary Outcomes (1)

• The qualitative and quantitative effects of ajmaline provocation on parameters of cardiac conduction in healthy subjects using the surface electrocardiogram

  The investigators will be undertaking quantitative analysis of the changes in cardiac conduction observed in the presence of ajmaline. This is measured in time intervals in milliseconds (ms) and magnitude of electrical conduction which will be expressed in millivolts (mv), but can also be expressed in millimetres (mm). The investigators will use the latter to quantify area changes which will be expressed as millimetres squared (mm2). A quantitive description of the electrocardiographic patterns observed will also be performed in addition to further qualitative analysis of vectors created by the variety of ECG morphologies observed, this geometrical assessment will be measured in degrees. As this is a cohort of healthy volunteers the variations observed are anticipated to be part of the "normal" variation, therefore the statistical analysis of these findings will be as a cohort not individual.

  ten minutes

Secondary Outcomes (2)

• The influence of normal variations in right ventricular outflow tract dimensions on the electrocardiographic response to ajmaline provocation in healthy subjects using cardiac magnetic resonance imaging.

  intraoperative

• Genotype linkage analysis of the electrocardiographic response to ajmaline provocation in healthy subjects using candidate gene and gene wide association studies.

  through study completion, an average of 2 years

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

Once screened by the investigators, the participants will undergo ajmaline provocation, cardiac magnetic resonance imaging and genotype evaluation

Drug: Ajmaline

Interventions

Ajmaline DRUG

Ajmaline 1milligram/kilogram max dose as bolus intravenous over 10 minutes with continuous ECG monitoring

Also known as: GILURYTMAL

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic healthy Volunteers

You may not qualify if:

• Any prior cardiovascular illness
• Previous cardiac symptoms.
• History of unexplained syncope
• Any family history of proven sudden cardiac death or unexplained sudden death either in adulthood or infancy.
• Those unable to provide a two generation family history
• Abnormal resting ECG
• Any contraindications to cardiac magnetic resonance imaging
• Pregnant or breastfeeding women
• Intercurrent use of any medication known to be contraindicated in Brugada Syndrome

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's University Of London

London, United Kingdom

Location

MeSH Terms

Conditions

Brugada Syndrome; Death, Sudden

Interventions

Ajmaline; Prajmaline

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Elijah Behr, MD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: October 14, 2016
• Study Start: October 22, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)