HFSA ePoster Library

Introduction: Ischemic heart disease affects 48 million women in the US. The prevalence of heart failure (HF) is similar among women and men, but a majority of the newly diagnosed HF patients in the United States each year are women. Women with HF and reduced left ventricular ejection fraction are more symptomatic and have similar outcomes as men. Despite similar need for treatment, women represent only roughly 1 of every 5 patients enrolled in clinical trials for heart failure. A novel personalized approach to cell-based management of NYHA class II-III ischemic HF is being employed in the ongoing CardiAMP Cell Therapy HF trial (NCT02438306). An important screening criterion consists of a cell “potency” assay (CPA), whereby prospective subjects must demonstrate bone marrow quality having sufficient CD34+ cells, among other cell markers, to be included in the trial. The purpose of this analysis was to determine if there may be differences in the potential for female HF patients to meet the study CPA screening criterion and therefore be included in the trial.
Methods: For the CPA, bone marrow quality characteristics were evaluated using a biomarker panel, including determination of CD34+ cell concentration by flow cytometry. Of the 154 patients screened thus far, 138 (89.6%) are men. Average age is 63.7± 4.9 years for females and 66.5±11.5 for males.
Results: Concentration of CD34+ cells (Table) did not differ significantly between males and females (p=0.354). Females met the CPA criterion at a higher rate than males (75% vs 65%). All subjects who passed the CPA were successfully randomized into the cell therapy treatment or control arms per protocol.

Table 1: Female vs. Male CPA Analysis
	Male	Female
n	138	16
average age	66.5	63.7
CD34+ Concentration (k/ml)
Average	365	433
Stdev	292	268
Median	299	445
Cell Potency Assay Result
# met criterion	90/138	12/16
% met criterion	65%	75%

Conclusions: Women continue to be under enrolled in this HF trial. Preliminary results suggest that women may be more likely than men to meet the CPA criterion for study eligibility. Additional analyses are underway to evaluate other demographic measures that may be associated with bone marrow quality for autologous treatment of heart failure. While the trial continues to enroll, the importance of including more women into this and other HF research programs is vital to understand and improve outcomes for all patients.