Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hormone replacement therapy:effect on ventricular repolarization

    Drug

    Hormone replacement therapy and QTc measurement

  • ECG

    Diagnostic test

    QTc measurement

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Premature ovarian insufficiencyExperimental treatment 1 intervention
Group B: healthy volunteersOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
in the luteal phase between Day22 and Day25

Secondary outcomes

1

Duration of QTc

Measure the duration of QTc in women with POI before and after the introduction of HRT

Time frame
the day before and between Day22 and Day60 after the introduction of HRT
2

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

Time frame
in the luteal phase between Day22 and Day25

Other outcomes

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