Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Captopril Tablets, Iohexol.
- Who it may be relevant to
- Registry conditions: Hormone Therapy. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hormone Therapy and Angiotensin-Dependent Arterial and Renal
Overview
1. 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. 2. 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.
Detailed description
Participants are screened for eligibility.
Study involves a 4.5 hour morning in the lab:
1. Participants come fasting 2. IV infusion and blood draws 3. Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks
Interventions
- Drug Captopril Tablets
Captorpril challenge to each participant - Drug Iohexol
Iohexol infusion to evaluate measured GFR
Primary outcome measures
- First association in transgender women and cis women [Time frame: 2025]
- Second association in transgender men and cis men [Time frame: 2025]
Eligibility criteria
Inclusion criteria
- Age 18 to 90 years
- Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Canada · 1 center
- University of Calgary — Calgary
Identifiers
NCT: NCT05442463 · REB19-0460