To demonstrate the arrhythmogenic action of MSG in a single blinded placebo controlled test on these patients with reported MSG induced AF and to investigate the possibility of MSG as a potential trigger for AF.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study will be AF, confirmed by Holter or 12-lead
ECG.
Secondary outcome
Secondary endpoints are two or more symptoms of the MSG symptom complex.
Background summary
There is anecdotal evidence of patients with atrial fibrillation triggered by
ingestion of monosodiumglutamate (MSG), also known as Ve-Tsin or E621.
Glutamate is the principal excitatory neurotransmitter in the brain but
receptors have been found on the myocardium and cardiac nerve tissue. Our
hypothesis is that glutamate has an arrhythmogenic potential and can induce
atrial fibrillation (AF).
Study objective
To demonstrate the arrhythmogenic action of MSG in a single blinded placebo
controlled test on these patients with reported MSG induced AF and to
investigate the possibility of MSG as a potential trigger for AF.
Study design
Single blind placebo study.
Study burden and risks
Patients will be required to be admitted three times for a period of two hours
with an interval of one week after each admission. Patients can experience
discomforting symptoms provoked by AF after ingestion of MSG orally. During
admission blood samples will be taken at regular intervals to measure glutamate
blood levels. After admission patients undergo Holter monitoring for 24h.
During the study the patients are required to maintain a MSG-free diet. If a
relationship between MSG ingestion and AF occurence is established these
patients can benefit from this study by adhering to the MSG-free diet.
Furthermore if this study suggests a relationship other patients with AF can be
informed of the effects of this potential arrhythmogenic food additive.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Reported monosodiumglutamate triggered atrial fibrillation
Age is between 18 and 80 years
AF is symptomatic and paroxysmal
AF was documented on ECG, Holter or pacemaker electrogram at least once in the 6 months preceding presentation
In sinus rhythm at the moment of study inclusion
Legally competent and willing and able to sign informed consent
Willing and able to adhere to the follow up visit protocol
Exclusion criteria
Myocardial infarction (defined as CKMB> twice upper limit of normal) within the preceding 2 months
NYHA class IV/IV heart failure symptoms, or class II-III with a recent decompensation requiring hospitalization (unless related to or aggravated by AF)
Cerebrovascular accident (defined as any sudden neurological deficit lasting longer than 24 hours, with or without pathological changes on the CT cerebrum) with the preceding 6 months
Known and documented carotid stenosis>80%
Pregnancy or of childbearing potential without adequate contraception
Requirement of antiarrhythmic medication for ventricular arrhythmias
Left ventricular ejection fraction<30%
Severely enlarged left atrium: left atrial volume index>40 ml/m2 or left atrial diameter>52 mm
History of previous radiation therapy on the thorax
Circumstances that prevent follow-up (no permanent home or address, transient, etc.)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31448.018.10 |