NCT04167033 Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)
| NCT ID | NCT04167033 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Premature Ovarian Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-04-14 |
| Primary Completion | 2027-04-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2021-04-14 with a primary completion date of 2027-04-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Anne Bachelot, Pr
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04167033 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Premature Ovarian Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04167033 currently recruiting?
Yes, NCT04167033 is actively recruiting participants. Contact the research team at anne.bissery@aphp.fr for enrollment information.
Where is the NCT04167033 trial being conducted?
This trial is being conducted at Bordeaux, France, Paris, France, Paris, France.
Who is sponsoring the NCT04167033 clinical trial?
NCT04167033 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Anne Bachelot, Pr at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 120 participants.