Project Summary Heart failure (HF) with preserved ejection fraction (HFpEF) is most common form of HF in the US and is associated with high morbidity and mortality. HFpEF disproportionately affects women and non-Hispanic Black persons. HFpEF is now understood as a heterogeneous syndrome intertwined with aging and multiple comorbidities, and likely has multiple phenotypes. The pathophysiology remains incompletely understood and few evidence-based treatments exist. This is the premise for HeartShare, a pivotal NHLBI initiative, whose ultimate goals are to discover novel biological signals that will lead to actionable targets to inform future HFpEF interventions.10 HeartShare is developing a Registry of 10,000 HF patients and matched comparators, and a comprehensive 1000 participant Deep Phenotyping cohort. The Deep Phenotyping arm has to date recruited 262 participants from 7 sites. Of these, 80%, are White, and only 11% are African American, considerably below the expected goal. There has developed a broad consensus among HeartShare stakeholders that additional effort and support are needed to develop and implement strategies to help achieve diversity goals, and specifically for a ‘Diversity Champion’ approach. Without the urgent, coordinated intervention in this proposal to enhance inclusivity, participant diversity is likely to continue to be suboptimal, jeopardizing HeartShare’s validity and generalizability. The Wake Forest-Atrium HeartShare Clinical Site has a diverse investigator team, has consistently exceeded diversity enrollment targets in many clinical studies, and to date leads overall Heart Share enrollment and has the highest percentage of female participants and the second highest percentage of Black participants among the 7 sites. The overall goal of this proposal is to enhance enrollment of under-represented groups across HeartShare sites by carrying out the following Aims: 1) Completing a comprehensive assessment of resources and strategies for enrolling URM participants at each of the clinical sites across HeartShare, as well as outcomes to date; 2) Utilizing the results of the comprehensive assessment to develop optimal practices for enrollment of URM participants in HeartShare, test and refine them at Wake Forest’s site, and then disseminate and help implement them across all HeartShare sites; 3) Continuously monitor progress and dynamically adjust strategies as needed to help ensure optimal participant diversity and inclusion across HeartShare. Our proposal is supported by: 1) An unexpected, compelling need in a pivotal, ongoing NHLBI study; 2) Preliminary data indicating lack of a cohesive, robust, organized approach to diversity and inclusion; 3) a diverse, multi-disciplinary leadership team consisting of a promising minority female early career investigator combined with highly experienced senior investigators and staff, who together have developed a strong track record for diverse participant enrollment in HeartShare and multiple other trials; 4) enthusiastic support of the HeartShare Data Translational Center and Clinical Sites.

Narrative HeartShare seeks to enroll persons with heart failure with preserved ejection fraction (HFpEF), a complex and poorly understood disease, as well as control participants, into an observational study designed to clarify the causes of HFpEF. Non White persons are more likely to have HFpEF but have been underrepresented in prior research and in HeartShare itself thus far; after 1/4th of recruitment is completed, less than 20% are non-White (goal is 40% non White enrollment). Thus we propose appointing a Diversity Champion to work closely with the HeartShare study leaders to accomplish the following: comprehensively assess resources and strategies for enrolling minority participants at each of the 7 clinical sites, use the results of the assessment to develop optimal practices for diversifying enrollment tailored to each site’s population, share these practices with HeartShare sites, and to continuously monitor progress and dynamically adjust strategies as needed to help ensure optimal participant diversity and inclusion across HeartShare.