The Response To Ajmaline Provocation in Healthy Subjects

St George's, University of London

Status and phase: Unknown; Phase 2

Conditions: Sudden Death; Brugada Syndrome

Treatments: Drug: Ajmaline

Study type: Interventional

Funder types: Other

Identifiers

NCT02933437

16.0012

2016-004277-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The investigators will recruit healthy subjects without a history of cardiac symptoms or a family history of sudden death or premature arrhythmogenic cardiac disease. Participants will undergo electrocardiographic phenotype assessment with standard and high lead electrocardiogram and sodium channel provocation. Detailed cardiac structural examination will be performed with cardiac magnetic resonance imaging to look for any variation in mainly right ventricular outflow tract structure and myocardial architecture. Participants will also undergo targeted genomic sequencing to look for variations in genes encoding for cardiac sodium channel.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Asymptomatic healthy Volunteers

Exclusion criteria

• • 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Healthy Volunteers

Experimental group

Description:

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

Treatment:

Drug: Ajmaline