Actively Recruiting
Cardiovascular Health of Transgender Individuals During the Clinical Gender-affirming Pathway
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-09-23
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of gender incongruence
- Age 18 years or older at the start of therapy
- Undergoing gender-affirming hormone therapy with testosterone or estradiol plus anti-androgens for at least 12 months
- Provision of informed consent for study participation and data processing
You will not qualify if you...
- Any hormone therapy received before recruitment
- History of cardiovascular events prior to the initiation of hormone therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From baseline through study completion, estimated to be up to 13 years
Participants are monitored throughout their gender-affirming hormone therapy to assess cardiovascular health, including vital signs, blood tests, body composition, and insulin resistance.
Regular visits scheduled as part of routine clinical care
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, BO, Italy, 40138
Actively Recruiting
Research Team
M
Maria Cristina Meriggiola, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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