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Clinical Trials in France / NCT04167033
Recruiting Not applicable

Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)

NCT04167033 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2021-04-14
Last updated
2025-12-09

Condition(s) studied

Premature Ovarian Insufficiency

Investigational drug(s) / intervention(s)

Hormone replacement therapy:effect on ventricular repolarizationECG

Hormone replacement therapy:effect on ventricular repolarization: Hormone replacement therapy and QTc measurement

ECG: QTc measurement

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Duration of QTc — in the luteal phase between Day22 and Day25
    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

Trial sites (3)

FacilityCityRegionStatus
Hopital Haut Leveque Bordeaux France Active Not Recruiting
BACHELOT Paris France Recruiting
Pitié Salpêtrière Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04167033 on ClinicalTrials.gov ↗ ← All trials in France