EN RAPPORT
Research type
Research Study
Full title
Establishing normative ranges for cardiopulmonary function and physiology for transgender people: a pilot, feasibility study
IRAS ID
333229
Contact name
Jayanth Arnold
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
Recent reports suggest that at least 0.5% of the population in England and Wales are transgender; as with cisgender people, transgender people may require cardiovascular care. However, to date, there are no published references ranges for cardiopulmonary function in transgender people, and no data on how gender affirming hormone treatment affects cardiopulmonary function. This information is vital for the care of transgender people as they age. Despite the increasing numbers of people identifying as transgender, medical studies involving this population are scarce, reflecting the complexities of recruiting transgender people into clinical trials.
The aim of this study is to establish cardiopulmonary reference ranges for transgender people on cross-gender hormone treatment. The study (arm 1) will test the feasibility of recruiting transgender subjects aged ≥ 18 years who have undergone cross-gender hormone treatment for ≥ 2years. Study assessments will include magnetic resonance imaging to measure cardiac volumetry/function and cardiopulmonary exercise testing. We will also evaluate research participation among transgender people and identify potential barriers to their participation. The data from this pilot study will provide appropriate data to power a larger, definitive study subject to further external grant funding.
In a separate study arm (arm 2), an anonymous survey will be conducted via Twitter to explore potential barriers to research participation.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0080
Date of REC Opinion
25 Apr 2024
REC opinion
Further Information Favourable Opinion