Cardiomodulatory Effects of Gender-Affirming Hormone Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gender Incongruence, Cardiovascular Disease (CVD) Risk Factors. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Primary outcome measures
- Change in left ventricular mass (g) [Time frame: 6-12 months]
Secondary outcome measures (12)
- Change in left ventricular end-systolic volume (LVES) and end-diastolic volume (EDV) (mL) [Time frame: 6-12 months]
- Change in left ventricle ejection fraction (LVEF) (%) [Time frame: 6-12 months]
- Change in concentration of circulating cardiac biomarkers [Time frame: 6-12 months]
- Change in concentration in markers of blood lipids [Time frame: 6-12 months]
- Change in concentration in markers of cardiometabolic risk factors such as insulin resistance [Time frame: 6-12 months]
- Changes in global longitudinal strain (GLS) (%) and global circumferential strain (GCS) (%) [Time frame: 6-12 months]
- Change in arterial stiffness assessed as the pulse wave velocity (m/s) [Time frame: 6-12 months]
- Change in arterial stiffness assessed as the aortic distensibility (mmHg-1) [Time frame: 6-12 months]
- Change in blood pressure (mmHg) [Time frame: 6-12 months]
- Change in body mass index (BMI) [Time frame: 6-12 months.]
- Change in body composition [Time frame: 6-12 months.]
- Change in self-reported health-related quality of life (SF-36) [Time frame: 6-12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- Oslo University Hospital — Oslo
Identifiers
NCT: NCT07128771 · 522599