British Heart Foundation - ROMA:Women

The Global Cardiovascular Research Funders Forum (GCRFF) launched the Multinational Clinical Trials Initiative in 2021, aiming to helping researchers in different countries collaborate on multinational clinical trials that might not be feasible in a single country or with support from a single funder. ROMA:Women, the first cardiac surgery trial enrolling only women, was one of the first clinical trials endorsed by the initiative. 

Led in the UK by Professor Gavin Murphy at the University of Leicester, the trial investigates whether multiple arterial grafts (MAG) improve outcomes in coronary artery bypass grafting (CABG) compared to single arterial grafts with additional vein grafts (SAG). MAG may offer better long-term results but is not often used in the UK – and even less often in women – as it’s a more technically difficult surgery with a higher risk of wound complications. Previous trials underrepresented women, leaving gaps in evidence. ROMA:Women aims to close this gap. 

The team behind ROMA:Women is addressing this knowledge gap by carrying out the first ever cardiac surgery trial to involve only women. Building on and using the existing infrastructure of the ROMA trial (which enrolled 690 women), it aims to involve a total of 2000 women undergoing CABG, recruited from hospitals across the UK and up to 18 other countries worldwide. Participants will be randomly assigned to receive either MAG or SAG during their surgery and followed up for up to four years to assess whether there is a difference in long term outcomes. 

If significant benefit is found, ROMA:Women could lead to a change in clinical guidelines, more women receiving MAG, and improved outcomes for women undergoing CABG. As CABG is the most commonly performed heart surgery in adults worldwide, the findings have the potential to improve the health of many millions of women. 

ROMA:Women was included as a case study in the Inclusivity Checklist for Clinical Research, launched in April 2025. As of April 2025, UK enrolment was ahead of target, and this approach is an example for researchers to consider when designing trials for women or other under-represented groups. To encourage greater participation of women, the majority of the trial’s governance and oversight positions are held by women, and patient representatives are involved throughout. The team also identified potential barriers to recruitment by interviewing women who declined to participate in ROMA or ROMA:Women.