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Study identifier: NCT07187947 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway

Condition: Gender Incongruence · Cardiovascular (CV) Risk · Cardiovascular Disease Risk Factor  ·  Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

PhaseN/A
Planned participants500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Gender incongruence, now classified in ICD-11 as a "marked and persistent incongruence between an individual's experienced gender and the gender assigned at birth," is managed in dedicated, multidisciplinary centres that coordinate psychological support with medical-surgical care. Gender-affirming hormone therapy (GAHT) is central to this care pathway. In particular, masculinising GAHT for people assigned female at birth (AFAB) relies mainly on testosterone, and feminising or demasculinising GAHT for people assigned male at birth (AMAB) combines oestradiol with androgen-lowering agents such as cyproterone acetate or GnRH analogues (triptorelin, leuprorelin). In addition, Gender-affirming surgery (GAS) offers further individualised options: "Top" procedures- chest masculinisation for AFAB or breast augmentation for AMAB, and "Bottom" procedures\*\* such as hysterectomy with or without oophorectomy, phalloplasty or metoidioplasty for AFAB; orchiectomy or vaginoplasty for AMAB. Other ancillary interventions include facial feminisation or voice surgery. GAHT aims to suppress endogenous sex-hormone levels and secondary sex characteristics while inducing those consistent with the affirmed gender. Despite its widespread use, cardiovascular (CV) safety data are scant and largely observational. Sex-steroid receptors are ubiquitous in the vasculature and contribute to the sex-dimorphic patterns of CV risk seen in cisgender populations; GAHT is therefore biologically plausible as a mo…

This description comes directly from the study's public registry record.

Talk to the study team

Maria Cristina Meriggiola, MD, PhD  ·  +390512144394  ·  cristina.meriggiola@unibo.it

Always discuss trial participation with your own doctor first.

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'OrsolaBologna, BO, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07187947