Cardiovascular effects of gender-affirming hormones in adults
Cardiovascular Health of Transgender Individuals During the Clinical Gender-affirming Pathway
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07187947
This project tests whether masculinizing or feminizing gender-affirming hormone therapy changes heart and blood vessel health in transgender adults who have been on hormones for at least 12 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT07187947 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort at a tertiary center in Bologna following transgender adults receiving either masculinizing (testosterone) or feminizing (estradiol plus androgen-lowering agents) gender-affirming hormone therapy. Participants are adults with a diagnosis of gender incongruence who have been on continuous hormone therapy for at least 12 months and who have no prior cardiovascular events. The study collects clinical data and cardiovascular risk markers over time to characterize changes in cardiovascular health associated with GAHT. All participation requires informed consent and follow-up visits at the coordinating center.
Who should consider this trial
Good fit: Adults (18+) with diagnosed gender incongruence who have been receiving continuous masculinizing or feminizing gender-affirming hormone therapy for at least 12 months and who have no history of cardiovascular events are ideal candidates.
Not a fit: People with prior cardiovascular events, those not on GAHT or on GAHT for less than 12 months, and minors are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, results could clarify hormone-related cardiovascular risks and help clinicians and patients choose safer, more informed hormone regimens.
How similar studies have performed: Previous observational studies have reported mixed findings, showing some changes in lipids, blood pressure, and thrombotic risk with GAHT while randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of gender incongruence * Age 18 years or older at the start of therapy * Undergoing gender-affirming (replacement or suppressive) hormone therapy with testosterone or with estradiol plus anti-androgens for at least 12 months * Provision of informed consent for study participation and for the processing of personal and sensitive data Exclusion Criteria: * Any hormone therapy received before recruitment * History of cardiovascular events prior to the initiation of hormone therapy
Where this trial is running
Bologna, BO
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola — Bologna, BO, Italy (RECRUITING)
Study contacts
- Study coordinator: Maria Cristina Meriggiola, MD, PhD
- Email: cristina.meriggiola@unibo.it
- Phone: +390512144394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gender Incongruence, Cardiovascular Risk, Cardiovascular Disease Risk Factor, Cardiovascular Disease Acute, Cardiovascular Health Status, Cardiovascular Disease, Cardiovascular Disease Prevention, cardiovascular risk