Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans
ConditionHormone Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity of Calgary
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 90 years
Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)
Disqualifiers
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
Trial population
Healthy adult ages 18 - 90 years cisgender (gender identity that aligns with sex at birth) and transgender (gender identity that does not align with sex at birth) adult women and men who are on oral, non-oral or no hormone therapy.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Captopril Tablets
DrugCaptorpril challenge to each participant
Iohexol
DrugIohexol infusion to evaluate measured GFR
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Cisgender and transgender women2 interventions
Group B: Cisgender and transgender men2 interventions
Trial outcomes
Primary outcomes
1
First association in transgender women and cis women
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.
Time frame
20252
Second association in transgender men and cis men
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.
Time frame
2025Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov