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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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
How many people
450 participants
Where
1 siteNorway
Study dates
5 Sep 2025to Oct 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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.

Norway1 site

  • Oslo University Hospital

    Oslo, Oslo

Other trials in Norway

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 groups in NCT07128771
Study groupRoleWhat they receive
Patients receiving gender-affirming hormone therapyPatients receiving gender-affirming hormone therapy at Oslo University Hospital with a diagnosis of gender-incongruence
Control groupAge-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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Change in blood pressure (mmHg)

    Blood pressure, both systolic and diastolic blood pressure, will be measured in a standardized manner.

    Measured: 6-12 months

  10. 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.

  11. Change in body composition

    Body composition will be evaluated using dual-energy x-ray absorptiometry (DXA).

    Measured: 6-12 months.

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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.

  1. First posted19 Aug 2025
  2. Study start5 Sep 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Gender Incongruence and Cardiovascular Disease (CVD) Risk Factors, run by University Hospital, Akershus at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in left ventricular mass (g) (time frame: 6-12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07128771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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