Hormone Therapy and Angiotensin-Dependent Arterial and Renal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- First association in transgender women and cis women
研究概览
简要总结
- to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
- to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.
详细描述
Participants are screened for eligibility.
Study involves a 4.5 hour morning in the lab:
- Participants come fasting
- IV infusion and blood draws
- Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 90 years
- •Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)
排除标准
- •Cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
- •Cerebrovascular disease (transient ischemic attacks or stroke)
- •History of hypertension (BP>140/90 or use of antihypertensive medications)
- •Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
- •Diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose >7mmol/L)
- •Current smoker
- •Previous history of preeclampsia
- •Anabolic steroids, cortical steroids, or non-steroidal anti-inflammatory medications, or at the discretion of the investigator.
研究组 & 干预措施
Cisgender and transgender women
Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally.
Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.
干预措施: Captopril Tablets (Drug)
Cisgender and transgender women
Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally.
Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.
干预措施: Iohexol (Drug)
Cisgender and transgender men
Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally.
Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.
干预措施: Captopril Tablets (Drug)
Cisgender and transgender men
Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally.
Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.
干预措施: Iohexol (Drug)
结局指标
主要结局
First association in transgender women and cis women
时间窗: 2025
to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
Second association in transgender men and cis men
时间窗: 2025
to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.
次要结局
未报告次要终点
研究者
Sofia Ahmed
Principal Investigator
University of Calgary