Cardiomodulatory Effects of Gender-Affirming Hormone Therapy

Gender-affirming hormone therapy is today a well-established treatment for individuals experiencing gender-incongruence. However, little is known about the long-term effects of gender-affirming hormone therapy on the cardiovascular system and it is unknown whether gender-affirming hormone therapy is associated with negative, neutral or perhaps positive effects on cardiovascular risk factors. The aim of the study The Cardiomodulatory Effects of Gender-Affirming Hormone Therapy (CARMEN) is therefore to contribute to fill this important knowledge gap by a longitudinal assessment of the affect of gender-affirming hormone therapy with a detailed characterization using state of the art methods for cardiovascular imaging, circulating biomarker assessment, body composition, and self-reported health-related quality of life. The information obtained will inform both candidates for gender-affirming hormone therapy, their families, health personnel and health policy decision makers about the cardiometabolic effects and cardiovascular risks of such therapy and will be relevant information in shared decision-making processes.

The aim of this study is using a prospective and cross-sectional observational design, to assess the effect of initiation and effect of gender-affirming hormone therapy in trans men (female to male) and in trans women (male to female) on: * Cardiovascular risk factors, including blood pressure, body mass index, body composition, and blood lipids * Cardiovascular function, structure and anatomy as assessed by cardiovascular magnetic resonance (CMR) imaging and transthoracic echocardiography * Circulating cardiovascular and inflammatory biomarkers assessed by immunoassays and proteomic profiling * Self-reported health-related quality of life. The study will have one longitudinal group where 60 trans women and 60 trans men are followed from the start of treatment till 6-12 months after. An age-matched control group will go through the same assessments. The second part of the study will be cross-sectional, where the investigators aim to include 100 trans women and 100 trans men already on gender-affirming hormone therapy and being followed at Oslo University Hospital by an endocrinologist. In both these group, patients who both previously or currently are using Gonadotropin-releasing hormone agonists (GnRH-agonists), so called puberty blockers, will also be eligible for inclusion.