Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-12 @ 2:48 PM
Study NCT ID:
NCT04167033
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}, {'id': 'D016171', 'term': 'Torsades de Pointes'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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)."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-11-15', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of QTc', 'timeFrame': 'in the luteal phase between Day22 and Day25', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Duration of QTc', 'timeFrame': 'the day before and between Day22 and Day60 after the introduction of HRT', 'description': 'Measure the duration of QTc in women with POI before and after the introduction of HRT'}, {'measure': 'Duration of QTc', 'timeFrame': 'in the luteal phase between Day22 and Day25', 'description': 'Study the association between sex hormone levels (gonadotropins, steroid hormones) and QTc duration, as well as their variation in patients with POI and healthy volunteers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premature ovarian insufficiency', 'QTc', 'Torsade de pointe', 'Hormone replacement therapy'], 'conditions': ['Premature Ovarian Insufficiency']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Ventricular repolarization, measured by the duration of the heart rate corrected QT interval (QTc), is influenced by sex hormones. A QTc above 460msec predisposes to the risk of torsades-de-pointes (TdP); ventricular arrhythmias that can lead to sudden death.\n\nFrom puberty to menopause, QTc is longer in women than in men (\\~10-15msec difference) and varies in women according to the menstrual cycle (\\~5-10msec). This explains the increased risk of TdP in women compared to men. During the menstrual cycle, the risk is highest for women during the follicular phase compared to the luteal phase. 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.\n\nPremature ovarian insufficiency (POI) affects 1% of women under 40 years of age and is characterized by hypergonadotropic hypogonadism. POI is associated with hormonal deficiencies responsible for amenorrhea and infertility. 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. HRT will be based on the combination of an estrogen and a progestin and will lead to a variable decrease in gonadotropins, depending on the steroid hormones/doses used. Our team, after structuring one of the largest international cohorts of patients with POI, is interested in the effect of this pathological hormonal situation and its HRT on ventricular repolarization to define whether this is a population at risk for long QTc. Indeed, ECG follow-up is recommended and many drugs (cardiovascular or not), are to be avoided, or even contraindicated in situations at risk of long QTc.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with POI\n\n* Patient aged 18 to 41 years\n* Patient with POI diagnostic criteria (FSH \\>25UI/l twice at intervals of a few weeks) with amenorrhea\n* No hormone treatment interacting with the gonadotropic axis for at least one month before inclusion\n* Patient who has signed informed consent\n* Patient affiliated to a social security system\n\nHealthy volunteers (including POI control group)\n\n* 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\n* Women with regular cycles of 26 to 32 days\n* Women who has signed an informed consent form\n* Patient affiliated to a social security system\n\nExclusion Criteria:\n\nPatients with POI\n\n* Patient on HRT during the 1st evaluation\n* Pregnant or breastfeeding woman\n* Treatment regimen known to lengthen QT or act on ventricular repolarization\n* Cardiac history in particular cardiac rhythm disorder\n* Diabetes\n* Patient on AME (unless derogation from affiliation),\n* Severe renal insufficiency (MDRD \\<30ml/min/m²)\n\nHealthy volunteers (including POI control group)\n\n* Diabetes or any chronic disease (including cardiovascular and endocrine)\n* Pregnant or breastfeeding woman\n* Hormonal contraceptive treatment in progress or stopped less than 3 months ago\n* Chronic treatment affecting the duration of QTc\n* Woman under AME (unless affiliation derogation)'}, 'identificationModule': {'nctId': 'NCT04167033', 'acronym': 'QTIOP', 'briefTitle': 'Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Study of Ventricular Repolarization in Patients With Premature Ovarian Insufficiency and Influence of Estrogen-progestin Replacement Therapy', 'orgStudyIdInfo': {'id': 'APHP180160'}, 'secondaryIdInfos': [{'id': '2019-A01002-55', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Premature ovarian insufficiency', 'description': '60 patients with POI followed in the endocrinology department', 'interventionNames': ['Drug: Hormone replacement therapy:effect on ventricular repolarization']}, {'type': 'OTHER', 'label': 'healthy volunteers', 'description': "60 healthy volunteers matched with POI's patients", 'interventionNames': ['Diagnostic Test: ECG']}], 'interventions': [{'name': 'Hormone replacement therapy:effect on ventricular repolarization', 'type': 'DRUG', 'description': 'Hormone replacement therapy and QTc measurement', 'armGroupLabels': ['Premature ovarian insufficiency']}, {'name': 'ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'QTc measurement', 'armGroupLabels': ['healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Hopital Haut Leveque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'BACHELOT Anne, Pr', 'role': 'CONTACT', 'email': 'anne.bachelot@aphp.fr', 'phone': '01 42 16 02 46'}, {'name': 'DULON Jérôme', 'role': 'CONTACT', 'email': 'jerome.dulon@aphp.fr', 'phone': '01 42 16 02 11'}], 'facility': 'BACHELOT', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'SALEM Joe Elie', 'role': 'CONTACT'}], 'facility': 'Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Anne Bissery, MD', 'role': 'CONTACT', 'email': 'anne.bissery@aphp.fr', 'phone': '1 42 16 24 32', 'phoneExt': '+33'}, {'name': 'Fredy Pene, Mr', 'role': 'CONTACT', 'email': 'fredy.pene@aphp.fr', 'phone': '1 42 16 24 35', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Anne Bachelot, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Joe Elie Salem, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}