About this trial
Ventricular repolarization, measured by corrected QT interval (QTc), is influenced by sex hormones. A QTc above 460msec predisposes to the risk of "torsades-de-pointes"(TdP). The investigators have recently shown that estradiol determines an increase in QTc elongation and progesterone shortens it. In addition, high gonadotropin levels (FSH or LH) are associated with QTc prolongation. Hypergonadotropic hypogonadisms (low progesterone and high gonadotropins) are therefore hormonal situations that promote QTc prolongation. Premature ovarian insufficiency (POI) is one of them. Its management is based on the prescription of hormone replacement therapy (HRT). Epidemiological studies have shown that these patients would be at increased risk of cardiovascular mortality. Our team is interested in the effect of this pathological hormonal situation and its HRT on ventricular repolarization in order to define whether this is a population at risk for long QTc.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient aged 18 to 41 years
Patient with POI diagnostic criteria (FSH >25UI/l twice at intervals of a few weeks) with amenorrhea
No hormone treatment interacting with the gonadotropic axis for at least one month before inclusion
Patient who has signed informed consent
Disqualifiers
Patient on HRT during the 1st evaluation
Pregnant or breastfeeding woman
Treatment regimen known to lengthen QT or act on ventricular repolarization
Cardiac history in particular cardiac rhythm disorder
Trial design
Parallel
Treatments tested in this trial
Hormone replacement therapy:effect on ventricular repolarization
DrugHormone replacement therapy and QTc measurement
ECG
Diagnostic testQTc measurement
Treatment groups
Trial outcomes
Primary outcomes
Duration of QTc
Compare the duration of QTc in patients with non-substituted POI with that of matched healthy volunteers on cardiovascular risk factors. The QTc will be measured by the Fridericia method
Secondary outcomes
Duration of QTc
Measure the duration of QTc in women with POI before and after the introduction of HRT
Duration of QTc
Study the association between sex hormone levels (gonadotropins, steroid hormones) and QTc duration, as well as their variation in patients with POI and healthy volunteers
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