NCT07732452尚未招募4 期
HER BRAVE HEART Trial - Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition: A Randomized Feasibility Study
McGill University Health Centre/Research Institute of the McGill University Health Centre0 个研究点目标入组 100 人开始时间: 2026年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Recruitment Rate
研究概览
简要总结
The goal of this clinical trial is to learn whether it is feasible to conduct a larger study comparing transdermal menopausal hormone therapy (MHT) versus no hormone therapy in menopausal women with vasomotor symptoms (hot flashes and night sweats) and at least one cardiovascular risk factor. The main questions it aims to answer are:
- What proportion of eligible women agree to be randomly assigned to either receive MHT or not?
- How many participants complete the 12-month follow-up, including repeat heart imaging?
- Does transdermal MHT affect early changes in heart muscle tissue as measured by cardiac MRI?
Researchers will compare immediate initiation of transdermal estradiol (a skin gel or patch) to a no-hormone therapy strategy to see if MHT influences early cardiovascular and brain-vascular changes over 12 months.
Participants will:
- Be randomly assigned to start transdermal MHT within 2 weeks, or to use no hormone therapy for at least the first 3 months
- Undergo a cardiac MRI and retinal eye imaging at the start of the study and again at 12 months
- Complete cognitive testing and questionnaires about symptoms, sleep, and stress at both visits
- Provide a blood sample for storage and future analysis of heart and brain health markers
- Receive follow-up phone calls at 3, 6, and 9 months to review symptoms, medications, and any health changes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 45 years.
- •Perimenopausal or postmenopausal, defined as at least one of the following:
- •Perimenopause, defined as menstrual cycle irregularity (changes in cycle length, skipped cycles, or amenorrhea ≥ 60 days) accompanied by vasomotor symptoms consistent with the menopausal transition.
- •Postmenopause, defined as at least one of:
- •≥ 12 months of spontaneous amenorrhea, or
- •bilateral oophorectomy, or
- •hysterectomy with FSH > 40 IU/L when menstrual history is unavailable.
- •Vasomotor symptoms with a negative impact on quality of life, defined as :
- •Recurrent hot flashes (sudden sensations of heat, typically involving the face, neck, or chest, often associated with flushing and/or sweating), and/or
- •Night sweats (episodes of excessive sweating during sleep), With associated interference in daily functioning, sleep, or overall quality of life, such that the participant would be an appropriate candidate for systemic menopausal hormone therapy in clinical practice.
- •Presence of at least one cardiovascular risk factor, defined as either:
- •Hypertension (diagnosed hypertension, use of antihypertensive medication, or blood pressure ≥ 140/90 mmHg on screening).
- •Dyslipidemia (diagnosed dyslipidemia, use of lipid-lowering therapy, LDL ≥ 3.0 mmol/L, or total cholesterol ≥ 5.2 mmol/L).
- •Type 2 diabetes mellitus, defined as HbA1c ≥ 6.5%, fasting plasma glucose ≥ 7.0 mmol/L, or use of glucose-lowering medication.
- •Obesity (body mass index ≥ 30 kg/m²).
- •Current smoking.
- •First-degree family history of premature cardiovascular disease, defined as myocardial infarction, stroke, or documented coronary artery disease occurring before age 55 years in a male relative or before age 65 years in a female relative.
- •Eligible for systemic MHT (i.e., no formal contraindication to MHT).
- •Able and willing to undergo research CMR and attend the 12-month follow-up assessment.
- •Able to provide written informed consent.
- •Not currently using systemic MHT at baseline, or willing to discontinue systemic MHT prior to randomization and remain off systemic MHT until allocation and baseline assessments are complete.
排除标准
- •Prior cardiovascular event or established cardiovascular disease, including myocardial infarction, stroke or TIA, coronary artery disease, heart failure, cardiomyopathy, or clinically significant valvular heart disease.
- •Uncontrolled hypertension or other unstable cardiovascular condition (e.g., unstable angina, decompensated heart failure, uncontrolled arrhythmia).
- •Formal contraindication to systemic menopausal hormone therapy, including estrogen-dependent cancer, unexplained vaginal bleeding, active severe liver disease, severe thrombophilia, antiphospholipid syndrome, prior or active VTE.
- •Standard contraindications to MRI (e.g., MRI-incompatible pacemakers or intracardiac devices, certain metallic implants, metallic foreign bodies in the eye, or severe claustrophobia not manageable).
- •Pregnant.
- •Active cancer on ongoing cardiotoxic chemotherapy.
- •Current use of systemic hormonal therapy outside the study strategy, including systemic menopausal hormone therapy, combined hormonal contraception, or systemic progestin-only contraception, with unwillingness or inability to discontinue prior to baseline and randomization.
- •Ten years or more since menopause, defined as ≥10 years from the final menstrual period or from bilateral oophorectomy
- •Participants currently using combined hormonal contraception or systemic progestin-only contraception who are willing to discontinue must complete a washout period of at least 4 weeks prior to the baseline visit and randomization
研究组 & 干预措施
Transdermal Menopausal Hormone Therapy
Experimental
干预措施: Transdermal estradiol (Drug)
结局指标
主要结局
Recruitment Rate
时间窗: At enrollment
Proportion of eligible women approached who consent to randomization, Percentage (%)
12-Month Retention Rate
时间窗: 12 months
Proportion of randomized participants completing the 12-month follow-up visit, Percentage (%)
CMR Completion Rate
时间窗: 12 months
Proportion of participants completing both baseline and 12-month CMR examinations, Percentage (%)
Crossover Rate
时间窗: 12 months
Proportion of participants in the no-MHT group who initiate systemic MHT during follow-up, Percentage (%)
次要结局
- Myocardial oxygenation reserve(Baseline and 12 months)
- Aortic distensibility(Baseline and 12 months)
- Aortic cross-sectional area(Baseline and 12 months)
- Left ventricular ejection fraction (LVEF)(Baseline and 12 months)
- Left ventricular end-diastolic volume (LVEDV)(Baseline and 12 months)
- Left ventricular end-systolic volume (LVESV)(Baseline and 12 months)
- Left ventricular mass (LVM)(Baseline and 12 months)
- LV mass-to-volume ratio (concentricity)(Baseline and 12 months)
- Global longitudinal strain (GLS)(Baseline and 12 months)
- Superficial retinal capillary plexus vessel density(Baseline and 12 months)
- Deep retinal capillary plexus vessel density(Baseline and 12 months)
- Foveal avascular zone (FAZ) area(Baseline and 12 months)
- FAZ perimeter(Baseline and 12 months)
- PROMIS Cognitive Function Short Form 8a score(Baseline and 12 months)
- RBANS Total Scale Score(Baseline and 12 months)
- Global native myocardial T1 according to vasomotor symptom burden(Baseline)
- LVEF according to vasomotor symptom burden(Baseline)
- Multivariable regression analysis of baseline predictors of 12-month change in global native myocardial T1(Baseline and 12 months)
研究者
Judy Luu
MD/PhD, FRCPC
McGill University Health Centre/Research Institute of the McGill University Health Centre
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