2026-526442-28-00招募中4 期
Effects of Menopausal Hormone Therapy on QTc in Genetically Confirmed Long QT Syndrome: A Prospective Randomized Sequential Crossover Study with Long-Term Observational Follow-Up (LQTS-HER)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Maximum change in QTc (ΔQTc, ms) on ECG from baseline during each 4-week MHT treatment period.
研究概览
简要总结
To evaluate the effect of different menopausal hormone therapy (MHT) regimens on maximum QTc (corrected QT interval) change (ΔQTc) from baseline in peri- and postmenopausal women with genetically confirmed long QT syndrome (LQTS).
研究设计
- 分配方式
- Na
- 主要目的
- Part 2: Observational follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex, age ≥18 years.
- •Genetically confirmed LQTS.
- •Perimenopausal or postmenopausal with clinical indication for systemic MHT, or with a documented clinical indication for systemic MHT due to estrogen deficiency of other reason.
- •Perimenopausal participants who cannot be confirmed as WNCBP (woman of no child-bearing potential) must agree to use adequate non-estrogen-containing contraception through Part 1 of the trial..
排除标准
- •Baseline QTc >= 520 ms.
- •Comorbidities significantly affecting arrhythmic risk or study participation. This includes, but is not limited to, structural heart disease, clinically significant coronary artery disease, myocardial infarction within the previous 12 months, heart failure with reduced ejection fraction (HFrEF), clinically relevant cardiomyopathies, severe hypokalemia, hypocalcemia or hypomagnesemia, severe renal or hepatic dysfunction or other medical conditions known to increase the risk of ventricular arrhythmias or to confound QTc assessment based on evaluation by the investigator.
- •Ongoing use of exogenous sex hormone preparations, including MHT, combined oral contraceptives, or other systemic estrogen, progestogen, or androgen preparations at the time of screening, unless the participant agrees to discontinue prior to enrolment and complete a washout period of at least 14 days before the screening visit.
- •Contraindications to MHT: All contraindications listed in SmPC of each IMP are considered exclusion criteria of this trial. In case of uncertainty, the treating investigator shall consult the principal investigator before enrolment. Contraindications to systemic MHT include, but are not limited to, the following:o Current, previous, or suspected breast cancer (familial breast cancer alone is not a contraindication) o Known or suspected estrogen-sensitive malignant conditions or concurrent treatment with an aromatase inhibitor
- •o Unresolved menstrual disorder (e.g., meno-metrorrhagia or undiagnosed vaginal bleeding) and/or lack of a routine gynecological examination within the past 5 years by a general practitioner or gynecologist. o Active or recent (< 1 year) venous thromboembolism (VTE), including deep vein thrombosis or pulmonary embolism o Known thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency) o Active or recent (< 1 year) arterial thromboembolic disease, including angina pectoris or myocardial infarction o Active liver disease, or history of liver disease where liver function tests have failed to return to normal o Porphyria cutanea tarda o Pregnancy
- •Hypersensitivity to the active substance or any of the excipients listed in the SmPC
- •Inability to comply with monitoring or follow-up. Participants who are unable or unwilling to receive an ILR may still be enrolled in the study; however, these participants will not contribute data to the methodological correspondence analysis between ILR- and ECG-derived QTc measurements.
- •Participants under judicial supervision, guardianship, or curatorship.
研究组 & 干预措施
Utrogestan 100 mg myk kapsel
Test
干预措施: Utrogestan 100 mg myk kapsel (Drug)
ESTRADIOL, NORETHISTERONE ACETATE
Test
干预措施: ESTRADIOL (Drug)
ESTRADIOL, NORETHISTERONE ACETATE
Test
干预措施: NORETHISTERONE ACETATE (Drug)
Estrogel 0,75 mg/dose transdermalgel
Test
干预措施: Estrogel 0,75 mg/dose transdermalgel (Drug)
Estradot 50 mikrog/24 timer depotplaster
Test
干预措施: Estradot 50 mikrog/24 timer depotplaster (Drug)
Lenzetto 1,53 mg/spray transdermal spray, oppløsning
Test
干预措施: Lenzetto 1,53 mg/spray transdermal spray, oppløsning (Drug)
结局指标
主要结局
Maximum change in QTc (ΔQTc, ms) on ECG from baseline during each 4-week MHT treatment period.
Maximum change in QTc (ΔQTc, ms) on ECG from baseline during each 4-week MHT treatment period.
次要结局
- Secondary safety endpoint: Occurrence and number of specific VAs during each MHT period and follow-up, as detected by ILR monitoring.
- Exploratory endpoint: Within-subject differences in maximum change in QTc (ΔQTc, ms) on ECG between different MHT regimens.
- Exploratory endpoint: Agreement between semi-manual QTc measured on ILR recordings and QTc obtained from concurrent standard 12-lead ECG recordings
- Secondary safety endpoint: Occurrence and number of severe VAs during Part 2, as detected by ILR monitoring.
- Exploratory endpoint: Change in QTc (ΔQTc, ms) from Part 1 baseline to each Part 2 follow-up visit during MHT prescribed in routine clinical care.
- Exploratory endpoint: Change in Menopause Rating Scale total score from the end of Part 1 to each Part 2 follow-up visit.
研究者
Kristina H Haugaa
Scientific
Oslo Universitetssykehus HF
研究点 (3)
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