Study of Ventricular Repolarization in Patients With Premature Ovarian Insufficiency and Influence of Estrogen-progestin Replacement Therapy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
France
Hopital Haut Leveque
ACTIVE_NOT_RECRUITING
Bordeaux
BACHELOT
RECRUITING
Paris
Pitié Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Anne Bissery, MD
anne.bissery@aphp.fr
1 42 16 24 32
Backup
Fredy Pene, Mr
fredy.pene@aphp.fr
1 42 16 24 35
Time Frame
Start Date: 2021-04-14
Estimated Completion Date: 2024-04-13
Participants
Target number of participants: 120
Treatments
Experimental: Premature ovarian insufficiency
60 patients with POI followed in the endocrinology department
Other: healthy volunteers
60 healthy volunteers matched with POI's patients
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov