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Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)

RecruitingNAAges 18 Years - 40 YearsFemaleAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Patients with POI * 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 * Patient affiliated to a social security system Healthy volunteers (including POI control group) * Healthy women, aged 18 to 40 years, age-matched (+/- 5 years), and by BMI class (BMI\<18, 18-25, 25-30, 30-35, 35-40, \>40) compared to women with BPI * Women with regular cycles of 26 to 32 days * Women who has signed an informed consent form * Patient affiliated to a social security system Exclusion Criteria: Patients with POI * 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 * Diabetes * Patient on AME (unless derogation from affiliation), * Severe renal insufficiency (MDRD \<30ml/min/m²) Healthy volunteers (including POI control group) * Diabetes or any chronic disease (including cardiovascular and endocrine) * Pregnant or breastfeeding woman * Hormonal contraceptive treatment in progress or stopped less than 3 months ago * Chronic treatment affecting the duration of QTc * Woman under AME (unless affiliation derogation)
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What it tests

  • Hormone replacement therapy:effect on ventricular repolarization
  • ECG
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Where

3 sites
Hopital Haut Leveque
Bordeaux, France
BACHELOT
Paris, France
Pitié Salpêtrière
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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