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. 

The FDA 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. 

See the publications list to read about the results of the OWH-supported cardiovascular research.

OWH Funded Research in Cardiovascular Disease (year of funding listed in parentheses):

Ongoing Projects

• Sex-Specific Left Bundle Branch Block Criteria and ECG Scar Quantification to Predict Benefit from Cardiac Resynchronization Therapy (CRT) – David Strauss, MD, Special funding/CDRH (11)
• Addressing the unmet medical needs for cardioproctection in women receiving chemotherapy – Rao, Ashutosh, CDER (11)
• Preclinical Test Methods for Percutaneously Implanted Heart Valves: Effect of Non-Circular Valve Configuration After Implantation On Valve Leaflet Dynamics – Terry Woods, NCTR (11)
• 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)
• Sex-based differences in the molecular mechanisms of polymer degradation in drug eluting stents (DES) - Patwardhan, Dinesh, PhD, CDRH (11)
• Genetic and epigenetic mechanisms for sex differences in the kidney of a rat model system: developing safety biomarkers for FDA regulated products – James Fuscoe, PhD, NCTR (11)
• Atrial Fibrillation Ablation Registry Study  (SAFARI) - Ellen Pinnow, MPH, CDRH (10)
• Assessment of outcomes and bleeding complications following implantation of drug eluting stents (DES) and dual anti-platelet therapy (DAPT) - Hesha Duggirala, Ph.D, CDRH (10)
• Assessment of Risk Factors Associated with Exposure to Proton Pump inhibitors and Fracture and CV outcomes in post-menopausal osteoporosis woman - Antonio Paredes, CDER (10)
• 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)
• Risk of Adverse Events Following Cardiac Catheterization by Hemostasis Device Use – Phase III - Dale Tavris, MD, MPH, CDRH (10)

• Analysis of sex-differences in cardiac resynchronization therapy devices: inclusion, adverse events, and outcomes - Kathryn O'Callaghan, CDRH (09)
• Sex-based differences in the safety of drug-eluting stents containing bioresorbable materials - Dinesh Patwardhan, Ph.D., CDRH (09)

Completed Projects

• Workshop: Guidance for the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Devices - Kathryn O’Callaghan, CDRH (08)
• Gender-Related Differences in QT Effects and Torsade de Pointes Potential of Drugs - Christine Garnett, PharmD/ Phillip Dinh, PhD, CDER (08)
• Factors Accelerating the Progression of Heart Failure (HF) in Women: Implications for Drug Interactions with Medical Devices - Soma Kalb, PhD, CDRH (07)
• Drug Eluting Stent (DES)/Thrombosis - Bram Zukerman;  Norman Stockbridge, Duke Clinical Research Institute (07)
• Real-World Outcomes of Drug-Eluting Stents - Art Sedrakyan, MD, PhD, CDRH/AHRQ (07)
• 'Mechanisms of Gender Differences in Aspirin Effects: Metabolizing Enzymes and Therapeutic Targets - Baitang Ning, Ph.D., NCTR (07)
• The Impact of Sex-Based Differences in Atherosclerotic Plaque on the Response to Drug Eluting Stent Implantation - Dinesh Patwardhan, PhD, CDRH (07)
• Evaluation of Availability and Quality of Information Available on Females Included in Mechanical device Implant Trials - Kathryn O'Callaghan, CDRH (06)
• ECG Warehouse - Mortara Instruments Inc., Justin Mortara, PhD, Mortara Instruments Inc., (06)
• ECG Warehouse - Duke Clinical Research Institute and Duke University - Christopher Cabell, M.D., MHS, Duke Clinical Research Institute (DCRI) (06)
• Assessment of the Accuracy of the Troponin Assay and the Diagnosis of Myocardial Infarction by Gender - Azadeh Shoaibi, PhD/ Dale Tavris, MD, MPh, CDRH (05)
• Systems Biology Approach to Evaluate Sex Differences in Heart of a Rat Model - James C. Fuscoe, Ph.D., NCTR (05)
• Implications of Gender-based Differences in Cardiovascular Disease on Imaging for Treatment and Diagnosis - Iacovos Kyprianou, Ph.D., CDRH (05)
• Use and Outcomes of Coronary Stents in Women: Use of a National Medicare Database - Karen Freund, MD, Boston Univ (05)
• Transmission Attenuation Correction for Female Patients Undergoing Myocardial Perfusion Imaging: Correction for Confounding Breast Tissue Artifact - Michelle Dew, MD, Univ. of Arizona, (04)
• Pilot Study:  Combined Beta1 Arg 389 and Alpha 2c Del 322-325 Adrenergic Receptor Polymorphisms and Heart Failure with Preserved Left Ventricular Ejection Fraction in African American Women - Thierry LeJemtel, MD, Tulane Univ (04)
• Are Women at Higher risk from Proarrhythmic Drugs? - Jogarao Gobburu, PhD, CDER (03)
• Discovery and Evaluation of Interspecies Biomarkers to Monitor the Early Onset and the Progression of Cardiovascular Toxicity Associated with Thiazolidinedione Compounds Used in the Treatment of Type 2 Diabetes - Eugene Herman, PhD, CDER (03)
• Cardiovascular Effects Of Ultrasound Contrast Agents in Intact and Ovariectomized Female Animals - Melvin Stratmeyer, PhD, CDRH (03)
• Electrophysiological Characterization of Several Torsadogenic Drugs in Isolated Rabbit Hearts - John Koerner, PhD, CDER (03)
• Pharmacokinetics and Pharmacodynamics (PK/PD) of Atenolol in Pregnancy - Mary Hebert, PharmD, University of Washington, Dept of Pharmacy (02)
• Discovery and evaluation of interspecies biomarkers to identify and characterize the cardiotoxic effects of Transtuzumab (Herceptin), a novel antibody used in the treatment of breast cancer - Eugene Herman, PhD, CDER (01)
• Labetalol and Hypertension in Pregnancy: Pharmacokinetics and Pharmacodynamics - James Fischer, Ph.D. University of Illinois, Chicago (01)
• Women's participation in clinical drug trials for unstable angina and myocardial infarction - Ann Farrell, MD, CDER (00)
• Flow studies and the use of a waveguide in cardiovascular devices - Harvey Rudolf, PhD, CDRH (98)
• Ovarian steroids and cardiovascular disease: The role of gender in the effectiveness of interventional medical devices - James Karanian, PhD, CDRH (98)
• Variations in the drug-induced QT interval prolongation during the menstrual cycle - Ana Szarfman, MD, PhD, Raymond L. Woosley, MD, PhD, CDER (co-funded by NIH ORWH, 98)
• Epidemiology of medical devices in women - Danica Marinac-Dabic, MD, CDRH (97)
• A comparison of gender specific utilization of implantable cardioverter defibrillator therapy and post-implantation survivability - Steven Lascher, DVM, MPH, CDRH (97)
• Administration of thrombolytic therapy to women with acute myocardial infarction. Is it too late? - Emily B. Shacter, PhD, CBER (96)
• Gender differences in early and long-term results of coronary angioplasty with the Palmaz/Schatz stent - Danica Marinac-Dabic, MD, CDRH (95, 96, 97)
• Comparison of the beta-adrenergic antagonist actions of propranolol in men and women - David Flockhart, MD, PhD, CDER (94)
• Comparison of the potassium channel blocking actions of quinidine in men and women - Raymond L. Woosley, MD, PhD, CDER (94)
• Terfenadine/Oral contraceptive study - Lou Cantillina, MD, CDER (94)