Effects of hormone replacement therapy on heart function in women with premature ovarian insufficiency
Study of Ventricular Repolarization in Patients With Premature Ovarian Insufficiency and Influence of Estrogen-progestin Replacement Therapy
This study tests how hormone replacement therapy affects heart function in women under 40 with premature ovarian insufficiency to see if it changes their heart rhythm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Bordeaux and 2 other locations) |
| Trial ID | NCT04167033 on ClinicalTrials.gov |
What this trial studies
This study investigates how hormone replacement therapy (HRT) affects ventricular repolarization in women diagnosed with premature ovarian insufficiency (POI). It focuses on measuring the corrected QT interval (QTc) on ECG, which can indicate the risk of serious heart arrhythmias. The research aims to understand the relationship between hormonal levels and QTc prolongation, particularly in women under 40 with POI. By comparing these patients to healthy controls, the study seeks to identify potential cardiovascular risks associated with HRT in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 40 diagnosed with premature ovarian insufficiency.
Not a fit: Patients with pre-existing cardiac conditions or those currently on hormone replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify cardiovascular risks in women with premature ovarian insufficiency and optimize hormone replacement therapy to improve their heart health.
How similar studies have performed: Other studies have indicated hormonal influences on QTc prolongation, but this specific approach in the context of POI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bordeaux and 2 other locations
- Hopital Haut Leveque — Bordeaux, France (Active_not_recruiting)
- Bachelot — Paris, France (Recruiting)
- Pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Anne Bachelot, Pr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Anne Bissery, MD
- Email: anne.bissery@aphp.fr
- Phone: 1 42 16 24 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.