Protocol TRANS and QT Repolarization

Study Overview
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Brief Summary
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The consequences of hormonal treatment in transgender patients are still unknown. Thanks to the retrospective collection of control ECG data before and after hormone therapy, the impact of feminizing and masculinizing hormone treatment on ventricular repolarization in a population of treated transgender people, followed in the Endocrinology department of the Haut- Lévêque in Pessac, will be studied and compared with the cisgender population.

Detailed Description
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An essential step in the care of people with gender dysphoria is hormone therapy combining an anti-androgen and estrogen therapy in transgender women (formerly male to female) or androgen therapy in transgender men (female to male). Several studies have shown an increase in cardiovascular risk in these people treated and the European Society of Endocrinology also recommends the monitoring of cardiovascular risk factors in this risky population. Furthermore, sex steroid hormones as well as gonadotropins have been shown to be associated with the occurrence of ventricular arrhythmias in several animal and human studies. Indeed, from puberty to menopause, the QT is longer in women than in men in the general population. Moreover, it is well established that women are at particular risk of ventricular arrhythmia. Recent publications have also illustrated the shortening of QTc in women in a situation of biological hyperandrogenism and its lengthening in hypogonadal men. These data suggest that sex hormones do play a role in repolarization. Moreover, FSH also appears to be a major determinant positively correlated with the duration of ventricular repolarization. However, the ECG measurement of QT is a simple and non-invasive marker for evaluating this ventricular repolarization. To date, no study has yet focused on changes in cardiac repolarization in the transgender population treated with hormone therapy. Therefore, the aim of our study is to evaluate the impact of feminizing and masculinizing hormone treatment on ventricular repolarization in a population of treated transgender people, followed in the Endocrinology department of the Haut-Lévêque hospital in Pessac, compared to the cisgender population.

Official Title
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Analysis of Ventricular Repolarization by QT Measurement in Transgender People Treated With Hormone Therapy

Conditions
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Transgender Persons, QT Interval, Variation in

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Transgender people already treated coming for consultation as part of the usual follow-up in endocrinology for their gender dysphoria. Exclusion Criteria: Minor Patients under protective measures or deprived of liberty (under guardianship, curatorship, safeguard of justice, incarcerated) Drug acting on ventricular repolarization History of long QT syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treated transgender people<br>Transgender people treated (respectively feminizing hormone treatment in transgender women and masculinizing treatment in transgender men). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the impact of hormone treatment on QTc duration with ECG in treated transgender people (respectively feminizing hormone treatment in transgender women and masculinizing treatment in transgender men). | Difference in QTc duration (on digital ECG during a follow-up consultation for gender dysphoria, in endocrinology) in treated transgender people compared to a cisgender control group without hormonal abnormality. A global QT interval based on the 12-lead vector magnitude was automatically computed and then individually reviewed by a single blinded expert in QT measurement on the overlapped (superimposed) display of the representative waveforms. The QT interval was measured and corrected for heart rate by Fridericia's formula (QTcF = QT/RR 0.33). | triplicate ECG was done just before hormon treatment then another triplicate ECG is done 6 months after hormon therapy initiation |