Gender IncongruenceCARMENNCT07128771
Cardiomodulatory Effects of Gender-Affirming Hormone Therapy
An observational study of Gender Incongruence and Cardiovascular Disease (CVD) Risk Factors, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gender Incongruence, Cardiovascular Disease (CVD) Risk Factors
- How many people
- 450 participants
- Where
- 1 siteNorway
- Study dates
- 5 Sep 2025to Oct 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients approved for gender-affirming hormone therapy by an endocrinologist at Oslo University Hospital.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Keywords
- gender incongruence, gender dysphoria, cardiovascular disease, troponin, NT-proBNP, proteomics, CMR, heart disease, blood pressure, echocardiography, sex hormones, cardiometabolic
- Medical subject headings
- Gender Dysphoria, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving gender-affirming hormone therapy | Patients receiving gender-affirming hormone therapy at Oslo University Hospital with a diagnosis of gender-incongruence | |
| Control group | Age-matched participants not receiving gender-affirming hormone therapy without the diagnosis of gender-incongruence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass (g)
Assessed by cardiac magnetic resonance (CMR) from baseline to end of study.
Measured: 6-12 months
Secondary outcomes (16)
Change in left ventricular end-systolic volume (LVES) and end-diastolic volume (EDV) (mL)
Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Measured: 6-12 months
Change in left ventricle ejection fraction (LVEF) (%)
Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Measured: 6-12 months
Change in concentration of circulating cardiac biomarkers
Cardiac biomarkers defined as cardiac troponins I and T measured by high sensitivity assays (hs-TnI and hs-TnT) (ng/L) and N-terminal proB-type natriuretic peptide (NT-proBNP) (ng/L), compared from baseline to end of study.
Measured: 6-12 months
Change in concentration in markers of blood lipids
Blood samples will be collected and assessed from baseline to end of study. Blood samples will include markers such as cholesterol, LDL, and HDL (mmol/L).
Measured: 6-12 months
Change in concentration in markers of cardiometabolic risk factors such as insulin resistance
Blood samples will be collected and assessed from baseline to end of study. Blood samples will include the marker HbA1c (mmol/mol).
Measured: 6-12 months
Changes in global longitudinal strain (GLS) (%) and global circumferential strain (GCS) (%)
Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Measured: 6-12 months
Change in arterial stiffness assessed as the pulse wave velocity (m/s)
Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Measured: 6-12 months
Change in arterial stiffness assessed as the aortic distensibility (mmHg-1)
Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Measured: 6-12 months
Change in blood pressure (mmHg)
Blood pressure, both systolic and diastolic blood pressure, will be measured in a standardized manner.
Measured: 6-12 months
Change in body mass index (BMI)
Weight and height will be measured in a standarized manner and calculated into BMI (kg/m2).
Measured: 6-12 months.
Change in body composition
Body composition will be evaluated using dual-energy x-ray absorptiometry (DXA).
Measured: 6-12 months.
Change in self-reported health-related quality of life (SF-36)
For participants aged 18 years or older, the questionnaires SF-36 will be used. SF-36 gives eight scaled scores, each ranging from 0 to 100. Higher scores indicates better health-related quality of life.
Measured: 6-12 months
Change in self-reported health-related quality of life (PedsQL)
For patients aged 16-18, the questionnaire PedsQL will be used. Each question is scored 0-4 and each item response is linearly transformed to a 0-100 scale where higher scores indicate better health-related quality of life.
Measured: 6-12 months
Change in self-reported health-related quality of life (GHQ-12)
For participants aged 18 years or older, the questionnaires GHQ-12 will be used. The scale goes from 0 to 36 (Likert Method) with higher values indicating greater psychological stress.
Measured: 6-12 months
Change in self-reported health-related quality of life (SDQ)
For participants aged 16-18 years of age, the questionnaire SDQ will be used. The scale goes from 0 to 50 with higher values indicating increasing symptoms of difficulties.
Measured: 6-12 months
Change in self-reported health-related quality of life (Chalders Fatigue Questionnaire)
For all participants, the questionnaire Chalders Fatigue Questionnaire will be used. The scale goes from 0 to 33 with higher values indicating increasing symptoms of fatigue.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start5 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender IncongruenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University of Oslo
- Responsible party
- Principal investigator, Torbjorn Omland, University Hospital, Akershus
- Investigators
- Torbjørn Omland, MD, PhD, MPH, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128771
- Sponsor's protocol ID
- 522599
- Acronym
- CARMEN
- Status last verified
- Jan 2026
- First submitted
- 30 May 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is due to data protection considerations.