Informations générales (source: ClinicalTrials.gov)
Study of Ventricular Repolarization in Patients With Premature Ovarian Insufficiency and Influence of Estrogen-progestin Replacement Therapy
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
avril 2021
avril 2024
04 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:20:19 | Contacter | |||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| BACHELOT - 75013 - Paris - France | BACHELOT Anne, Pr | Contact (sur clinicalTrials) | |||
| Hopital Haut Leveque - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Pitié Salpêtrière - 75013 - Paris - France | SALEM Joe Elie | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
Patients with POI
- Patient aged 18 to 40 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
Patients with POI
- Patient aged 18 to 40 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
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)