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. OWH has funded 57 studies (12 ongoing and 45 completed) that examine issues such as QT interval prolongation, cardiotoxicity from breast cancer drugs, and sex differences in various cardiac interventional therapies. The results of the completed studies have led to a better understanding of cardiovascular disease in women and contributed to the devlopment of guidance documents for drug and device development for men and women.
- Current OWH-funded Research on Cardiovascular Disease
- Completed OWH-funded Research on Cardiovascular Disease
Addressing the unmet medical needs for cardioprotection in women receiving chemotherapy - Ashutosh Rao, PhD/CDER (Supplementary funds)
Preclinical test methods for percutaneously implanted heart valves - effect of non-circular valve configuration after implantation on valve leaflet dynamics- Terry Woods, PhD/CDRH
Sex-specific outcomes with cardiac resynchronization therapy - Daniel Canos, PhD/CDRH (Support for implementation of FDASIA Section 907 Action Plan)
A pilot study for evaluating genetic influences on sex differences of drug-induced – proarrhythmia - Li Pang, MD/ NCTR
Novel therapeutic approaches to prevent drug-induced torsade de pointes - Norman Stockbridge, MD, PhD, CDER
Develop animal and cellular models to investigate the mechanisms of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine to support post-marketing surveillance of these antibody-based HER2-targeted therapies, and characterize novel seum biomarker of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine - Wen Jin Wu, MD, PhD, CDER
Calcium and material characterization in women using dual-energy computed tomography – Nicholas Petrick, PhD, CDRH
Blood pressure threshold for cardiovascular disease risk: an assessment of sex-based criterion - Ching-Wei Chang, NCTR
Sex differences in drug-induced QT prolongation and torsade de pointes: establishing an in vitro model for high-throughput screening and risk assessment of torsadogenic drugs - Li Pang, MD, NCTR
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:
D Strauss. Filling Information Gaps for Women in Medical Device Trials. FDA Voice Blog: June 2014.
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
Addressing the unmet medical needs for cardioproctection in women receiving chemotherapy – Rao, Ashutosh, CDER
Sex-based differences in the molecular mechanisms of polymer degradation in drug eluting stents (DES) - Patwardhan, Dinesh, PhD, CDRH