Participation of Transgender and Gender Diverse Persons in Cardiovascular Clinical Trials

Overview

Journal Am Heart J Plus

Specialty Cardiology & Vascular Diseases

Date 2024 Jul 29

PMID 39070126

Authors

Rodopi Stamatiou

Georgios Kararigas

Affiliations

Soon will be listed here.

Abstract

Study Objective: Transgender persons face increased risk in developing cardiovascular diseases due to administration of hormonal therapy used for gender expression, or due to the presence of other risk factors, such as minority stress and difficulty to have full access to health care. Even though the need for gender diversity in research has been identified, the number of clinical trials including transgender persons remains low. The aim of this study was to highlight gaps in inclusion of transgender individuals in cardiovascular clinical research.

Design Setting: A search in the pubmed.com database, as well as in the clinicaltrials.gov repository, was performed with search terms regarding transgender persons and cardiovascular diseases.

Main Outcome Measures: The inclusion of transgender persons in cardiovascular clinical trials was evaluated.

Results And Conclusions: This study revealed that there is only a small number of cardiovascular clinical trials including or studying transgender persons. This finding demonstrates the overall lack of clinical trials regarding cardiovascular health in transgender individuals and is indicative of their under-representation in clinical research.

Citing Articles

Special issue: Women and cardiovascular trials.

Volgman A Am Heart J Plus. 2024; 45:100427.

PMID: 39301428 PMC: 11410722. DOI: 10.1016/j.ahjo.2024.100427.

Uncovering the persistent gap: The ongoing challenge of integrating sex and gender in biomedical research.

Delgado J, Abadia M, Akyuz K, Goisauf M, Rodriguez-Arias D J Biomed Res. 2024; 39(1):18-22.

PMID: 39290125 PMC: 11873592. DOI: 10.7555/JBR.38.20240157.

References

Sacks D, Baxter B, Campbell B, Carpenter J, Cognard C, Dippel D . Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018; 13(6):612-632. DOI: 10.1177/1747493018778713. View

Rytz C, Beach L, Saad N, Dumanski S, Collister D, Newbert A . Improving the inclusion of transgender and nonbinary individuals in the planning, completion, and mobilization of cardiovascular research. Am J Physiol Heart Circ Physiol. 2023; 324(3):H366-H372. DOI: 10.1152/ajpheart.00494.2022. View

Ober C, Loisel D, Gilad Y . Sex-specific genetic architecture of human disease. Nat Rev Genet. 2008; 9(12):911-22. PMC: 2694620. DOI: 10.1038/nrg2415. View

Altinbas L, Bormann N, Lehmann D, Jeuthe S, Wulsten D, Kornak U . Assessment of Bones Deficient in Fibrillin-1 Microfibrils Reveals Pronounced Sex Differences. Int J Mol Sci. 2019; 20(23). PMC: 6928642. DOI: 10.3390/ijms20236059. View

Kararigas G . Sex-biased mechanisms of cardiovascular complications in COVID-19. Physiol Rev. 2021; 102(1):333-337. PMC: 8805735. DOI: 10.1152/physrev.00029.2021. View

Kararigas G, Dworatzek E, Petrov G, Summer H, Schulze T, Baczko I . Sex-dependent regulation of fibrosis and inflammation in human left ventricular remodelling under pressure overload. Eur J Heart Fail. 2014; 16(11):1160-7. DOI: 10.1002/ejhf.171. View

Casey L, Reisner S, Findling M, Blendon R, Benson J, Sayde J . Discrimination in the United States: Experiences of lesbian, gay, bisexual, transgender, and queer Americans. Health Serv Res. 2019; 54 Suppl 2:1454-1466. PMC: 6864400. DOI: 10.1111/1475-6773.13229. View

Rice E, Lan R, Nunes J, Shah R, Clark K, Periyakoil V . Who Are We Missing? Reporting of Transgender and Gender-Expansive Populations in Clinical Trials. J Am Heart Assoc. 2023; 12(22):e030209. PMC: 10727288. DOI: 10.1161/JAHA.123.030209. View

Maraka S, Ospina N, Rodriguez-Gutierrez R, Davidge-Pitts C, Nippoldt T, Prokop L . Sex Steroids and Cardiovascular Outcomes in Transgender Individuals: A Systematic Review and Meta-Analysis. J Clin Endocrinol Metab. 2017; 102(11):3914-3923. DOI: 10.1210/jc.2017-01643. View

10.

Tannenbaum C, Ellis R, Eyssel F, Zou J, Schiebinger L . Sex and gender analysis improves science and engineering. Nature. 2019; 575(7781):137-146. DOI: 10.1038/s41586-019-1657-6. View

11.

Hoffmann D, Tarzian A . The girl who cried pain: a bias against women in the treatment of pain. J Law Med Ethics. 2001; 29(1):13-27. DOI: 10.1111/j.1748-720x.2001.tb00037.x. View

12.

Steptoe A, Kivimaki M . Stress and cardiovascular disease. Nat Rev Cardiol. 2012; 9(6):360-70. DOI: 10.1038/nrcardio.2012.45. View

13.

Siokatas G, Papatheodorou I, Daiou A, Lazou A, Hatzistergos K, Kararigas G . Sex-Related Effects on Cardiac Development and Disease. J Cardiovasc Dev Dis. 2022; 9(3). PMC: 8949052. DOI: 10.3390/jcdd9030090. View

14.

Meerwijk E, Sevelius J . Transgender Population Size in the United States: a Meta-Regression of Population-Based Probability Samples. Am J Public Health. 2017; 107(2):e1-e8. PMC: 5227946. DOI: 10.2105/AJPH.2016.303578. View

15.

Pei J, Harakalova M, Treibel T, Lumbers R, Boukens B, Efimov I . H3K27ac acetylome signatures reveal the epigenomic reorganization in remodeled non-failing human hearts. Clin Epigenetics. 2020; 12(1):106. PMC: 7362435. DOI: 10.1186/s13148-020-00895-5. View

16.

. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018; 392(10159):1736-1788. PMC: 6227606. DOI: 10.1016/S0140-6736(18)32203-7. View

17.

Horvath C, Kararigas G . Sex-Dependent Mechanisms of Cell Death Modalities in Cardiovascular Disease. Can J Cardiol. 2022; 38(12):1844-1853. DOI: 10.1016/j.cjca.2022.09.015. View

18.

Goodman M . Understanding cardiovascular disease among transgender people: the journey continues. Eur J Prev Cardiol. 2022; 29(15):2015-2016. DOI: 10.1093/eurjpc/zwac182. View

19.

Hembree W, Cohen-Kettenis P, Gooren L, Hannema S, Meyer W, Murad M . Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017; 102(11):3869-3903. DOI: 10.1210/jc.2017-01658. View

20.

Kuyper L, Wijsen C . Gender identities and gender dysphoria in the Netherlands. Arch Sex Behav. 2013; 43(2):377-85. DOI: 10.1007/s10508-013-0140-y. View