Transgender IndividualsQTransNCT05865262
Protocol TRANS and QT Repolarization
An observational study of Transgender Individuals and QTc Interval, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The consequence of hormone-based treatment on cardiac electrophysiology in transgender individuals is poorly explored. We will investigate the effects of gender affirming hormone treatments on ventricular repolarization (ie. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transgender Individuals, QTc Interval
- What is being tested?
- ECG and blood test (assessing ionic and hormonal circulating levels)
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2021to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with gender dysphoria consulting as part of the usual standard of care follow-up in endocrinology for instauration or follow-up of GAHT
Who may be able to join
- Individuals with gender dysphoria consulting as part of the usual standard of care follow-up in endocrinology for instauration of the follow-up of GAHT
Who cannot join
- <18 years old
- patients under protective measures or deprived of liberty (under guardianship, curatorship, safeguard of justice, incarcerated)
- history of congenital long QT syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Ventricular Repolarization by QT Measurement in Transgender People Treated With Hormone Therapy
The consequence of hormone-based treatment on cardiac electrophysiology in transgender individuals is poorly explored. We will investigate the effects of gender affirming hormone treatments on ventricular repolarization (ie. QTc, QT corrected for heart rate duration) in a prospective cohort of transgender individuals before and after feminizing and masculinizing treatments, and transversally in transgender individuals on gender affirming hormone treatments. This monocentric cohort will be included in the Endocrinology department of the Haut-Leveque Hospital in Pessac (France).
Read the detailed description
An essential step in the care of gender dysphoria is gender-affirming hormone therapy (GAHT) 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 a detrimental effect of GAHT on cardiovascular risk factors and therefore, the European Society of Endocrinology recommend an enhanced monitoring of cardiovascular risk factors in transgender population. Data on the risk of cardiac arrhythmias in transgender population are lacking, particularly on ventricular repolarization and QTc.
Indeed, sex steroid hormones and gonadotropins are known to alter the cardiac electrophysiology, as shown in various animal and human studies. From puberty to menopause, the QTc is generally longer in women than in men, translating into a higher risk of Torsade de Pointes (a peculiar form of ventricular arrhythmia) in women versus men. Recent publications have well illustrated the shortening of QTc in women in situation of biological hyperandrogenism and; QTc lengthening in hypogonadal men which was reversed by restoration of physiological eugonadal testosterone levels. Gonadotrophin's levels were positively correlated with QTc. To date, no study has focused on changes in cardiac repolarization in the transgender population and particularly on the effects of GAHT.
The aim of this study is to evaluate the impact of feminizing and masculinizing hormone treatments (GAHT) on ventricular repolarization (i.e QTc) in transgender individuals, followed at the Endocrinology department of the Haut-Leveque hospital in Pessac.
We aim to enroll consecutively (monocentric cohort) transgender individuals (on and before treatment) consulting to the endocrinology department for their usual standard of care follow-up until we include 15 transgender men and 15 transgender women with 2 QTc assessments available, one before and the other after initiation of GAHT (triplicates of 10 sec ECGs, Fridericia's heart rate correction for each time-point). This effective (n=15/group) have ≥85% power to detect a difference in QTcF≥10msec between the ECG before and after initiation of GAHT with a paired t-test (α: 0.05; standard deviation of QTc in each subgroup: 12msec; expected QTcF mean: 410msec and 400msec in women and men before GAHT, respectively, intra-individual correlation: 0.5).
- Conditions
- Transgender Individuals, QTc Interval
- Being tested
- ECG, blood test (assessing ionic and hormonal circulating levels)
- Keywords
- Transgender, QTc, testoterone, estradiol, ventricular repolarization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
A triplicate ECG and a blood test will be done during a medical consultation as part of the usual endocrinology follow-up. Included individuals seen prior to initiation of GAHT, will be assessed a second time (at least one month after GAHT start) with a triplicate ECG and a blood test similar to inclusion visit. Included individuals already on GAHT will be seen only once at the inclusion visit.
Triplicates of 10seconds 12-lead digitized electrocardiogram will be recorded after few minutes of rest in the supine position. Electrocardiograms will be acquired with Mindray ECG BeneHeart R12. For each subject, RR, PR, QRS and QT interval durations will be assessed with a semiautomatic approach using the median representative beats (overlap method) generated from 10seconds ECG with a good quality (CalECG v3.7; AMPS, LLC). The QT interval will be measured and corrected for heart rate by Fridericia's formula.
blood test (assessing ionic and hormonal circulating levels)Diagnostic test
Blood samples for the determination of serum concentrations of estradiol, progesterone, testosterone, FSH, and LH will be collected on the same day as the ECG, in a dry tube and further assayed in the immunology laboratory of Bordeaux University Hospital (France). Estradiol, progesterone, FSH, and LH plasma concentrations will be assayed by immunochemiluminescence (Architect i2000SR; Roche Diagnostics), and testosterone levels by liquid chromatography mass spectrometry. Kalemia and calcemia will be collected in a BD Vacutainer tube with heparin lithium and separator, further assayed at the biochemistry laboratory of Bordeaux University Hospital by indirect potentiometric measurement (Architect c16000) and Arsenazo III SRM 956 colorimetrie (Architect c16000).
| Study group | Role | What they receive |
|---|---|---|
| treated transgender people | Transgender individuals consulting at the Endocrinology department of the Haut-Leveque hospital in Pessac (France), whether they are (one unique visit) or not (2 visits) already on GAHT (feminizing hormone treatment in transgender women and masculinizing treatment in transgender men, respectively). Men and women not already on GAHT will have two visits in total, one inclusion visit before GAHT start and one at least after one month of GAHT (and maximum within 2 years of start). Transgender individuals already on GAHT will have one unique inclusion visit without any planned follow-up visit. Receives: Diagnostic Test: ECG; Diagnostic Test: blood test (assessing ionic and hormonal circulating levels) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of GAHT on QTc duration in transgender individuals before and after starting therapy
Difference in QTc duration before and after initiation of GAHT
Measured: assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)
Secondary outcomes (3)
To assess the difference in PR, QRS, RR, QTc duration between men and women prior to GAHT, and transmen and transwomen already on GAHT.
Difference in PR, QRS, RR, QT, QTc duration on digital ECG at initial inclusion visit between men and women prior to GAHT, and transmen and transwomen already on GAHT
Measured: assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)
To assess the impact of gender-affirming hormone treatment on PR, QRS, RR duration in transgender individuals before and after starting GAHT
Difference in PR, QRS, RR duration before and after initiation of GAHT.
Measured: assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)
To assess the association between the hormonal and ionic levels with PR, QRS, RR, QTc duration in transgender individuals before and on GAHT.
Correlation (univariate and multivariate, including mixed effects models) between PR, QRS, RR, QTc duration and hormonal (progesterone, testosterone, FSH, LH, estradiol) and ionic (potassium, calcium) circulating levels
Measured: assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start16 Nov 2021
- Primary completion16 Nov 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender IndividualsStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- APHP
- Responsible party
- Principal investigator, Virginie GROUTHIER, University Hospital, Bordeaux
- Investigators
- Joe-Elie Salem, Pr, Study chair, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865262
- Sponsor's protocol ID
- 2021.11.16_Grouthier
- Acronym
- QTrans
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Ventricular Repolarization by QT Measurement in Transgender People Treated With Hormone Therapy
- ClinicalTrials.gov ID
- NCT05865262
- Acronym / sponsor ID
- QTrans / 2021.11.16_Grouthier
- Conditions
- Transgender Individuals, QTc Interval
- Keywords
- Transgender, QTc, testoterone, estradiol, ventricular repolarization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- APHP
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The consequence of hormone-based treatment on cardiac electrophysiology in transgender individuals is poorly explored. We will investigate the effects of gender affirming hormone treatments on ventricular repolarization (ie. QTc, QT corrected for heart rate duration) in a prospective cohort of transgender individuals before and after feminizing and masculinizing treatments, and transversally in transgender individuals on gender affirming hormone treatments. This monocentric cohort will be included in the Endocrinology department of the Haut-Leveque Hospital in Pessac (France).
Detailed description
An essential step in the care of gender dysphoria is gender-affirming hormone therapy (GAHT) 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 a detrimental effect of GAHT on cardiovascular risk factors and therefore, the European Society of Endocrinology recommend an enhanced monitoring of cardiovascular risk factors in transgender population. Data on the risk of cardiac arrhythmias in transgender population are lacking, particularly on ventricular repolarization and QTc.
Indeed, sex steroid hormones and gonadotropins are known to alter the cardiac electrophysiology, as shown in various animal and human studies. From puberty to menopause, the QTc is generally longer in women than in men, translating into a higher risk of Torsade de Pointes (a peculiar form of ventricular arrhythmia) in women versus men. Recent publications have well illustrated the shortening of QTc in women in situation of biological hyperandrogenism and; QTc lengthening in hypogonadal men which was reversed by restoration of physiological eugonadal testosterone levels. Gonadotrophin's levels were positively correlated with QTc. To date, no study has focused on changes in cardiac repolarization in the transgender population and particularly on the effects of GAHT.
The aim of this study is to evaluate the impact of feminizing and masculinizing hormone treatments (GAHT) on ventricular repolarization (i.e QTc) in transgender individuals, followed at the Endocrinology department of the Haut-Leveque hospital in Pessac.
We aim to enroll consecutively (monocentric cohort) transgender individuals (on and before treatment) consulting to the endocrinology department for their usual standard of care follow-up until we include 15 transgender men and 15 transgender women with 2 QTc assessments available, one before and the other after initiation of GAHT (triplicates of 10 sec ECGs, Fridericia's heart rate correction for each time-point). This effective (n=15/group) have ≥85% power to detect a difference in QTcF≥10msec between the ECG before and after initiation of GAHT with a paired t-test (α: 0.05; standard deviation of QTc in each subgroup: 12msec; expected QTcF mean: 410msec and 400msec in women and men before GAHT, respectively, intra-individual correlation: 0.5).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treated transgender people | – | Diagnostic Test: ECG, Diagnostic Test: blood test (assessing ionic and hormonal circulating levels)Transgender individuals consulting at the Endocrinology department of the Haut-Leveque hospital in Pessac (France), whether they are (one unique visit) or not (2 visits) already on GAHT (feminizing hormone treatment in transgender women and masculinizing treatment in transgender men, respectively). Men and women not already on GAHT will have two visits in total, one inclusion visit before GAHT start and one at least after one month of GAHT (and maximum within 2 years of start). Transgender individuals already on GAHT will have one unique inclusion visit without any planned follow-up visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with gender dysphoria consulting as part of the usual standard of care follow-up in endocrinology for instauration or follow-up of GAHT
Key inclusion criteria (1 listed)
- Individuals with gender dysphoria consulting as part of the usual standard of care follow-up in endocrinology for instauration of the follow-up of GAHT
Key exclusion criteria (3 listed)
- <18 years old
- patients under protective measures or deprived of liberty (under guardianship, curatorship, safeguard of justice, incarcerated)
- history of congenital long QT syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECGA triplicate ECG and a blood test will be done during a medical consultation as part of the usual endocrinology follow-up. Included individuals seen prior to initiation of GAHT, will be assessed a second time (at least one month after GAHT start) with a triplicate ECG and a blood test similar to inclusion visit. Included individuals already on GAHT will be seen only once at the inclusion visit. Triplicates of 10seconds 12-lead digitized electrocardiogram will be recorded after few minutes of rest in the supine position. Electrocardiograms will be acquired with Mindray ECG BeneHeart R12. For each subject, RR, PR, QRS and QT interval durations will be assessed with a semiautomatic approach using the median representative beats (overlap method) generated from 10seconds ECG with a good quality (CalECG v3.7; AMPS, LLC). The QT interval will be measured and corrected for heart rate by Fridericia's formula. | Diagnostic test | treated transgender people |
| blood test (assessing ionic and hormonal circulating levels)Blood samples for the determination of serum concentrations of estradiol, progesterone, testosterone, FSH, and LH will be collected on the same day as the ECG, in a dry tube and further assayed in the immunology laboratory of Bordeaux University Hospital (France). Estradiol, progesterone, FSH, and LH plasma concentrations will be assayed by immunochemiluminescence (Architect i2000SR; Roche Diagnostics), and testosterone levels by liquid chromatography mass spectrometry. Kalemia and calcemia will be collected in a BD Vacutainer tube with heparin lithium and separator, further assayed at the biochemistry laboratory of Bordeaux University Hospital by indirect potentiometric measurement (Architect c16000) and Arsenazo III SRM 956 colorimetrie (Architect c16000). | Diagnostic test | treated transgender people |
Primary outcome
To assess the impact of GAHT on QTc duration in transgender individuals before and after starting therapy
Time frame: assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)
Difference in QTc duration before and after initiation of GAHT
3 secondary outcomes
To assess the difference in PR, QRS, RR, QTc duration between men and women prior to GAHT, and transmen and transwomen already on GAHT.
Time frame: assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)
To assess the impact of gender-affirming hormone treatment on PR, QRS, RR duration in transgender individuals before and after starting GAHT
Time frame: assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)
To assess the association between the hormonal and ionic levels with PR, QRS, RR, QTc duration in transgender individuals before and on GAHT.
Time frame: assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe-Elie Salem, Pr study chair
Groupe Hospitalier Pitie-Salpetriere
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender Individuals and QTc Interval, run by University Hospital, Bordeaux at 1 site in France.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 12 Apr 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the impact of GAHT on QTc duration in transgender individuals before and after starting therapy (time frame: assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.