Clinical trial

Hormone Therapy and Angiotensin-Dependent Arterial and Renal

Name
REB19-0460
Description
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.
Trial arms
Trial start
2020-11-30
Estimated PCD
2025-11-30
Trial end
2025-11-30
Status
Recruiting
Treatment
Captopril Tablets
Captorpril challenge to each participant
Arms:
men, women
Size
200
Primary endpoint
First association in transgender women and cis women
2025
Second association in transgender men and cis men
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine, blood samples'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-05-10

1 organization

1 product

1 indication

Product
Captopril