Protocol TRANS and QT Repolarization

NCT05865262 | Completed

• 1 other identifier: 2021.11.16_Grouthier
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Transgender Individuals; QTc Interval

Keywords

Transgender; QTc; testoterone; estradiol; ventricular repolarization

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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

  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.

  assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started)

Study Arms (1)

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.

Diagnostic Test: ECG; Diagnostic Test: blood test (assessing ionic and hormonal circulating levels)

Interventions

ECG DIAGNOSTIC_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.

treated transgender people

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).

treated transgender people

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• \<18 years old
• patients under protective measures or deprived of liberty (under guardianship, curatorship, safeguard of justice, incarcerated)
• history of congenital long QT syndrome

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• APHP: collaborator

Study Sites (1)

University Hospital Bordeaux, France

Pessac, 336004, France

Location

MeSH Terms

Interventions

Electrocardiography; Hematologic Tests

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Joe-Elie Salem, Pr

  Groupe Hospitalier Pitie-Salpetriere

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Medical doctor

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 18, 2023
• Study Start: November 16, 2021
• Primary Completion: November 16, 2021
• Study Completion: January 1, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

FR (1)