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U.S. Department of Health and Human Services

Science & Research

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Research on Women and Heart Disease


Heart disease is the leading cause of death for women. Women often experience heart disease differently than men. For example, men have more heart attacks than women, but women have a higher heart attack death rate. Women experience higher bleeding rates during percutaneous coronary interventions (PCI) performed through femoral arterial access.  Women are also more susceptible to drug-induced cardiac arrhythmias. 


FDA's Office of Women's Health (OWH) supports research to provide valuable insight into sex differences in the diagnosis and treatment of cardiovascular disease. The studies listed on this page help to both improve regulatory decision-making and advance scientific knowledge on sex differences in the safety and efficacy of FDA-regulated medical products. 



OWH Funded Research on Cardiovascular Disease
Ongoing Projects (Listed by Funding Year)



PK analysis of the samples for a study funded by CDER Critical Pathways titled, “A double-blind, randomized, placebo-controlled single-dose, five-period crossover study of the electrocardiographic effects of ranolazine, dofetilide, verapamil and quinidine in healthy subjects” – David Strauss, MD, PhD, CDRH and Norman Stockbridge, MD, PhD, CDER



Novel Electrocardiogaphic Device Algroithms to Assess Cardiac Safety of Investigational Drugs – David Strauss, MD, PhD, CDRH


Gender-Specific Predictors of Heart Failure Hospitalization and Death in Cardiac Resynchronization Therapy - David Strauss, MD, PhD, CDRH

Publications from this project:

  • Z Loring, D Strauss, G Gerstenblith, G Tomaselli, R Weiss, K Wu. Women Have Less Myocardial Scar Than Men: Implications For Implantable Defibrillators And Cardiac Resynchronization Therapy. Heart Rhythm 2012; 9:S372, PO05-19.

  • Loring Z, Chelliah S, Selvester R, Wagner G, Strauss D. A detailed guide for quantification of myocardial scar with the Selvester QRS score in the presence of electrocardiogram confounders. Journal of Electrocardiology 2011; 44:544–554.


Investigate the mechanisms of trastuzumab-induced cardiotoxicity and cardiotoxicity and cardio protective role of antioxidants in trastuzumab-mediated cardiac dysfunction - Wen Jin Wu, MD, PhD, CDER

Publications from this project:

  • M. Khair El Zarrad, Partha Mukhopadhyay, Nishant Mohan1, Enkui Hao, Milos Dokmanovic, Dianne S.,Hirsch, Yi Shen1, Pal Pacher, Wen Jin W. Trastuzumab Alters the Expression of Genes Essential for Cardiac Function and Induces Ultrastructural Changes of Cardiomyocytes in Mice. PLoS ONE 8(11): e79543. doi:10.1371/journal.pone.0079543



Prospective assessment of clinical and patients-reported outcomes for female patients undergoing Percutaneous Coronary Intervention (PCI) procedures via femoral and radial access - Katie O'Callaghan, CDRH (11)


Addressing the unmet medical needs for cardioproctection in women receiving chemotherapy – Rao, Ashutosh, CDER (11)


Sex-based differences in the molecular mechanisms of polymer degradation in drug eluting stents (DES) - Patwardhan, Dinesh, PhD, CDRH (11)



The swan-ganz balloon flotation pulmonary artery catheter: possible racial and sex discrepancies - Daniel Canos, Ph.D,, CDRH (10)


Sex- and age- related differences in baseline QT, QT prolongation, and TdP risk - Christine Garnett, PharmD, CDER (10)



Analysis of sex-differences in cardiac resynchronization therapy devices: inclusion, adverse events, and outcomes - Kathryn O'Callaghan, CDRH (09)