Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans

Hormone Therapy Clinical Trial

Official title:

Hormone Therapy and Angiotensin-Dependent Arterial and Renal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442463
• Other study ID #: REB19-0460
• Status: Recruiting
• Start date: November 30, 2020
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: Darlene Y Sola, BScN
• Phone: 4032107434
• Email: dsola[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hormone Therapy

Intervention

Drug:
• Captopril Tablets
Captorpril challenge to each participant

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Dr. Sandra Dumanski

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2025
Primary	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.	2025