Cardiomodulatory Effects of Gender-Affirming Hormone Therapy (CARMEN)

University Hospital, Akershus

Status: Invitation-only

Conditions: Cardiovascular Disease (CVD) Risk Factors; Gender Incongruence

Study type: Observational

Funder types: Other

Identifiers

NCT07128771

522599

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of gender-incongruence
• Scheduled to initiate gender-affirming hormone therapy at Oslo University Hospital or currently being followed by an endocrinologist for gender-affirming hormone therapy at Oslo University Hospital
• Being 16 years or older

Exclusion criteria

- History of clinically significant cardiovascular disease

For the healthy controls, these exclusion criteria also apply:

• No daily smokers
• No endocrine disorders
• No daily medications (except contraception and seasonal medication such as antihistamines)

Trial design

450 participants in 2 patient groups

Patients receiving gender-affirming hormone therapy

Description:

Patients receiving gender-affirming hormone therapy at Oslo University Hospital with a diagnosis of gender-incongruence

Control group

Description:

Age-matched participants not receiving gender-affirming hormone therapy without the diagnosis of gender-incongruence