A study of the hearts response to the drug Ajmaline in healthy subjects

Phase 1

• Conditions: Study in the healthy population. This is a study of a test used in the diagnosis of the condition, Brugada Syndrome.; MedDRA version: 20.0Level: LLTClassification code 10003109Term: Arrest cardiacSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10003119Term: ArrhythmiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10059027Term: Brugada syndromeSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.1Level: LLTClassification code 10042436Term: Sudden death unexplainedSystem Organ Class: 100000004867; MedDRA version: 21.0Level: LLTClassification code 10069779Term: Brugada-type ECGSystem Organ Class: 100000004848; MedDRA version: 20.0Level: LLTClassification code 10008396Term: Change in ECGSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004277-41-GB
• Lead Sponsor: St George's University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-17
• Last Update Posted: 25 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Asymptomatic healthy individuals
Caucasian
Aged 18-65
Kidney function = 30ml/min/1.73m2
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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
Abnormal screening cardiac ultrasound
Any contraindications to cardiac magnetic resonance imaging participant has cardiac pacemaker; recent surgery; vascular clips; metal implants or joint replacements; have had metal fragments in their eyes; has ever worked on a lathe; has shrapnel from a war injury
Known allergy e.g. seafood, hayfever, hives
Pregnant or breastfeeding women
Male or pre-menopausal female participants of child-bearing potential* unwilling to use an effective method of birth control (either hormonal in the form of the contraceptive pill or barrier method of birth control accompanied by the use of a proprietary spermicidal foam/gel or film ; or agreement of true abstinence (i.e. withdrawal, calendar, ovulation, symptothermal and post ovulation are not acceptable methods) from time consent is signed until 6 weeks after the last dose of IMP
Enrolled on another CTIMP study
Intercurrent use of any medication known to be contraindicated in Brugada Syndrome
Any contraindication to ajmaline Provocation as detailed in the approved St George’s Hospital clinical ajmaline protocol.
*Subjects are only considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified