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

Sponsor

University of Calgary (Other)

Overall Status

Recruiting

CT.gov ID

NCT05442463

Collaborator

Dr. Sandra Dumanski (Other)

200

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hormone Therapy	Drug: Angiotensin II

Detailed Description

Participants are screened for eligibility.

Study involves a 4.5 hour morning in the lab:

Participants come fasting
IV infusions and blood draws
Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Hormone Therapy and Angiotensin-Dependent Arterial and Renal

Actual Study Start Date :

Nov 30, 2020

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
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. Angiotensin II is administered via IV: 3 ng/kg/min for 30 minutes then 6 ng/kg/min for 30 minutes. Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.	Drug: Angiotensin II Angiotensin II challenge to each participant
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. Angiotensin II is administered via IV: 3 ng/kg/min for 30 minutes then 6 ng/kg/min for 30 minutes. Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.	Drug: Angiotensin II Angiotensin II challenge to each participant

Arm

Intervention/Treatment

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. Angiotensin II is administered via IV: 3 ng/kg/min for 30 minutes then 6 ng/kg/min for 30 minutes. Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.

Drug: Angiotensin II

Angiotensin II challenge to each participant

men

Drug: Angiotensin II

Angiotensin II challenge to each participant

Outcome Measures

Primary Outcome Measures

First association in transgender women and cis women [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults over 18 to 90 years old will provide a wide range of individuals at different stages of hormonal use.

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), any 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. Excluding participants with these factors will reduce confounders when evaluating the study results.