QTc Interval Clinical Trial
— QTransOfficial title:
Analysis of Ventricular Repolarization by QT Measurement in Transgender People Treated With Hormone Therapy
Verified date | April 2024 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 120 |
Est. completion date | January 1, 2023 |
Est. primary completion date | November 16, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - <18 years old - patients under protective measures or deprived of liberty (under guardianship, curatorship, safeguard of justice, incarcerated) - history of congenital long QT syndrome |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Bordeaux, France | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | APHP |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started) | |
Secondary | 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. | assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started) | |
Secondary | 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 | assessments at inclusion and during follow-up visit in endocrinology department (minimum 1 month and max 2 years after treatment started) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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