Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)

NCT04167033 | Recruiting

• 2 other identifiers: APHP1801602019-A01002-55
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Premature Ovarian Insufficiency

Keywords

Premature ovarian insufficiency; QTc; Torsade de pointe; Hormone replacement therapy

Outcome Measures

Primary Outcomes (1)

• Duration of QTc

  Compare the duration of QTc in patients with non-substituted POI with that of matched healthy volunteers on cardiovascular risk factors. The QTc will be measured by the Fridericia method

  in the luteal phase between Day22 and Day25

Secondary Outcomes (2)

• Duration of QTc

  the day before and between Day22 and Day60 after the introduction of HRT

• Duration of QTc

  in the luteal phase between Day22 and Day25

Study Arms (2)

Premature ovarian insufficiency

EXPERIMENTAL

60 patients with POI followed in the endocrinology department

Drug: Hormone replacement therapy:effect on ventricular repolarization

healthy volunteers

OTHER

60 healthy volunteers matched with POI's patients

Diagnostic Test: ECG

Interventions

Hormone replacement therapy:effect on ventricular repolarization DRUG

Hormone replacement therapy and QTc measurement

Premature ovarian insufficiency

ECG DIAGNOSTIC_TEST

QTc measurement

healthy volunteers

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Hopital Haut Leveque

Bordeaux, France

ACTIVE NOT RECRUITING

BACHELOT

Paris, 75013, France

RECRUITING

Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Torsades de Pointes

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Tachycardia, Ventricular; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Anne Bachelot, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Joe Elie Salem, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Anne Bissery, MD

CONTACT

1 42 16 24 32; anne.bissery@aphp.fr

Fredy Pene, Mr

CONTACT

1 42 16 24 35; fredy.pene@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a bicentric case-control study: 60 patients with POI followed in the endocrinology department, and 60 healthy volunteers matched with POI's patients on age (+/- 5 years), on BMI classes (BMI\<18, 18-25, 25-30, 30-35, 35-40, \>40) and with regular cycles (26 to 32 days).

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: November 18, 2019
• Study Start: April 14, 2021
• Primary Completion (Estimated): April 13, 2027
• Study Completion (Estimated): June 13, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

FR (3)