RecruitingNot ApplicableNCT04167033

Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

120 participants

Start Date

Apr 14, 2021

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying ECG and a drug called Hormone replacement therapy:effect on ventricular repolarization for people with premature ovarian insufficiency. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 18 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHormone replacement therapy:effect on ventricular repolarization

Hormone replacement therapy and QTc measurement

DIAGNOSTIC_TESTECG

QTc measurement


Locations(3)

Hopital Haut Leveque

Bordeaux, France

BACHELOT

Paris, France

Pitié Salpêtrière

Paris, France

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NCT04167033


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