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RECRUITING
NCT04167033
NA

Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-04-14

Completion Date

2027-06-13

Last Updated

2025-12-09

Healthy Volunteers

Yes

Interventions

DRUG

Hormone replacement therapy:effect on ventricular repolarization

Hormone replacement therapy and QTc measurement

DIAGNOSTIC_TEST

ECG

QTc measurement

Locations (3)

Hopital Haut Leveque

Bordeaux, France

BACHELOT

Paris, France

Pitié Salpêtrière

Paris, France