Effects of Gender-Affirming Hormone Therapy Among Transgender Women

Cardiovascular Diseases Clinical Trial

Official title:

Effects of Gender-Affirming Hormone Therapy Among Transgender Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04128488
• Other study ID #: 2019P001962
• Secondary ID: 1K23HL147799-01
• Status: Active, not recruiting
• Start date: November 1, 2019
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, investigators plan to evaluate the cardiometabolic effects of initiating gender-affirming hormone therapy among transgender women with and without HIV. As part of this study, participants will undergo cardiovascular and metabolic phenotyping within 3 months of starting and after 12 months of gender-affirming hormone therapy. Cardiovascular phenotyping will include cardiac MRI/MRS imaging to evaluate cardiac function and structure. Metabolic phenotyping will include oral glucose tolerance testing, abdominal MR imaging to evaluate visceral adiposity, and whole body, lumbar, and hip DEXA imaging to evaluate fat and lean body mass as well as bone mineral density, respectively. Traditional markers of CVD risk as well as immune, hormonal, and coagulation parameters will also be assessed longitudinally.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 99 Years

Eligibility

Inclusion Criteria:

• transgender women or non-binary individual
• age =16
• For women with HIV only: on ART therapy for =3 months
• initiation of testosterone suppression with spironolactone or leuprolide and estrogen therapy with oral 17-ß estradiol, transdermal 17ß estradiol, sublingual estradiol, intramuscular estradiol, or subcutaneous estradiol by medical provider

Exclusion Criteria:

• For women with HIV only: CD4 count<50
• history of CAD, ACS, ASCVD risk score = 7.5%, LDL-C = 190, or angina (e.g. current indication for statin use)
• history of heart failure
• history of diabetes
• eGFR < 30 ml/min/1.73m2
• standard contraindication to MRI, including history of severe allergy to gadolinium or Dotarem
• prior orchiectomy
• gender-affirming hormone therapy for greater than 5 months directly prior to enrollment
• current or past anti-platelet therapy or anti-coagulant therapy within the last 6 months •current or past statin therapy within the last 6 months
• concurrent enrollment in conflicting research study

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coagulopathy
• HIV/AIDS
• Metabolic Disease
• Metabolic Diseases
• Transgender Women

Intervention

Other:
• Abdominal MR Imaging
Imaging to evaluate visceral adipose tissue and hepatic lipid content
• Cardiac MRI/MRS
Imaging to evaluate cardiac function and structure
• Oral Glucose Tolerance Testing
Blood testing to evaluate changes in glucose and insulin in response to oral glucose load
• Whole Body, Lumbar Spine, and Hip DEXA Imaging
Imaging to evaluate fat and lean body mass as well as bone mineral density

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Heart Association, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visceral Adipose Tissue		Baseline and 12 months
Secondary	Change in Intramyocardial Triglyceride Content on Cardiac MRS		Baseline and 12 months
Secondary	Change in Diastolic Function on Cardiac MRI		Baseline and 12 months
Secondary	Change in Myocardial Fibrosis on Cardiac MRI		Baseline and 12 months
Secondary	Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing		Baseline and 12 months
Secondary	Change in Bone Density		Baseline and 12 months
Secondary	Change in Hormonal Parameters		Baseline and 12 months
Secondary	Change in Coagulation Parameters		Baseline and 12 months
Secondary	Change in hepatic lipid content		Baseline and 12 months