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 65 studies (12 ongoing and 53 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 development 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
Capturing Sex-Specific Data in Regulatory Submissions and National Vascular Quality Initiative Registry - Danica Marinac-Dabic, MD, PhD/CDRH
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 (Supplementary funds)
A pilot study for evaluating genetic influences on sex differences of drug-induced – proarrhythmia - Li Pang, MD/ NCTR
Individual patient-data meta-analysis and post-market analysis as a method for improving data quality in demographic subgroups (Support for implementation of FDASIA Section 907 Action Plan) - Daniel Canos, PhD, MPH/CDRH
Novel therapeutic approaches to prevent drug-induced torsade de pointes - Norman Stockbridge, MD, PhD, CDER
- Vicente J, Simlund J, Johannesen L, Sundh F, Florian J, Ugander M, Wagner GS, Woosley RL, Strauss DG. Investigation of potential mechanisms of sex differences in quinidine-induced torsade de pointes risk. J Electrocardiol. 2015 Jul-Aug;48(4):533-8
- Vicente J, Johannesen L, Mason JW, Pueyo E, Stockbridge N, Strauss DG. Sex differences in drug-induced changes in ventricular repolarization. J Electrocardiol. 2015 Aug 4. pii: S0022-0736(15)00226-5. doi: 10.1016/j.jelectrocard.2015.08.004.
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 serum 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
Abdominal Aortic, Aneurysms: analysis of patient Characteristics and Anatomy Related to EVAR treatment and outcomes-AAA CARE - Tina Morrison PhD/CDRH