Actively Recruiting
Study on Cardiovascular Health in Adults Undergoing Gender-Affirming Hormone Therapy
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-09-23
500
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the cardiovascular health of transgender individuals undergoing gender-affirming care, specifically focusing on the effects of gender-affirming hormone therapy GAHT. This study aims to address gaps in knowledge about the long-term cardiovascular risks and mechanisms associated with GAHT, especially for people assigned female at birth AFAB receiving testosterone and those assigned male at birth AMAB receiving feminizing hormone therapy. The research highlights the need for robust, prospective data to better understand how GAHT impacts blood pressure, lipid profiles, and overall cardiovascular risk in transgender populations. The study observes transgender individuals receiving gender-affirming hormone therapy masculinizing GAHT with testosterone for AFAB participants and feminizing GAHT combining estradiol with anti-androgens like cyproterone acetate or GnRH analogues for AMAB participants. Some AMAB participants may receive estradiol alone after orchiectomy. Gender-affirming surgery is also part of the care pathway but is not the direct focus of the study. The investigation tracks changes in vital signs, blood tests, body composition, and insulin resistance over time while monitoring cardiovascular health outcomes. Participants will be followed from baseline through to study completion, estimated by 2035. They will undergo regular assessments including measurements of vital signs, anthropometric data, laboratory blood tests, and body composition analysis. Researchers will evaluate lifestyle habits and the presence or absence of cardiovascular disease, as well as how different GAHT regimens affect cardiovascular parameters. The study offers careful monitoring of cardiovascular risk factors in the context of gender affirmation, aiming to inform safer and more effective clinical guidelines for transgender health care.
CONDITIONS
Brief Title
Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway
Research Team
M
Maria Cristina Meriggiola, MD, PhD
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