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U.S. Department of Health and Human Services

Science & Research

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Completed OWH-funded Research Projects on Cardiovascular Disease

 

View Current OWH-Funded Research Projects

 

Women often experience heart disease differently than men. The FDA Office of Women's Health (OWH) supports research to help the FDA learn more about sex differences in the safety and efficacy of FDA-regulated medical products for the diagnosis and treatment of heart disease. The projects listed on this page have been completed. Publications highlighting the projects results are listed after the name of the project.

 

Completed Projects listed by Funding Year

 

2011

Preclinical Test Methods for Percutaneously Implanted Heart Valves: Effect of Non-Circular Valve Configuration After Implantation On Valve Leaflet Dynamics – Terry Woods, NCTR 

 

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

Publications from this project:

  • Kwekel JC, Desai VG, Moland CL, Vikrant V, Fuscoe JC. Life cycle analysis of kidney gene expression in male F344 rats. PloS One 2013; 8(10):e75305
  • Kwekel JC, Desai VG, Moland CL, Vikrant V, Fuscoe JC. Sex differences in kidney gene expression during the life cycle of F344 rats. Biol of Sex Differ 2013; 4(14)

 

2010

Atrial Fibrillation Ablation Registry Study (SAFARI) - Ellen Pinnow, MPH, CDRH (10)

Publication from this project:

  • Al- Khatib SM, Calkins H, Eloff BC, Kowey P, Hammill SC, Ellenbogen KA, Marinac-Dabic D, Waldo AL, Brindis R, Wilbur D, Jackman WM, Yaross MS, Russo A, Prystowsky E, Varosy P, Gross T, Pinnow E, Turakhia M, Krucoff MW. Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) As a Collaborative Pan-Stakeholder Critical Path Registry Model: A Cardiac Safety Research Consortium ‘Incubator’ Think Tank. Am Heart J. 2010; 160(4):619-26.

     

Assessment of outcomes and bleeding complications following implantation of drug eluting stents (DES) and dual anti-platelet therapy (DAPT) - Hesha Duggirala, Ph.D, CDRH

Publications from this project: 

  • Hess CN, McCoy LA, Duggirala HJ, et al. Sex-based differences in outcomes after percutaneous coronary intervention for acute myocardial infarction: A report from TRANSLATE-ACS. J Am Heart Assoc 2014; 3(1):e000523. 

 

Assessment of Risk Factors Associated with Exposure to Proton Pump inhibitors and Fracture and CV outcomes in post-menopausal osteoporosis woman - Antonio Paredes, CDER 

 

Risk of Adverse Events Following Cardiac Catheterization by Hemostasis Device Use – Phase III - Dale Tavris, MD, MPH, CDRH

Publications from this project:

  • Tavris DR Md, Gallauresi BA, Dey S, Brindis R, Mitchel K. Risk of local adverse events by gender following cardiac catheterization. Pharmacoepidemiology And Drug Safety 2007; 16:125–131.

  • Tavris DR, Dey S, Gallauresi BA, Brindis RG, Shaw R, Weintraub W, Mitchel K. Risk Of local adverse events following cardiac catheterization by hemostasis device use: phase II. J Invasive Cardiol 2005; 17(12):644-50.

  • Tavris DR, Gallauresi BA, Lin B, Rich SE, Shaw RE, Weintraub WS, Brindis RG, Hewitt K. Risk of local adverse events following cardiac catheterization by hemostasis device use and gender. J Invasive Cardiol 2004; 16(9):459-64.

  • Tavris DR, Gallauresi B, Rich S, Bell B, Relative risks of reported serious injury and death associated with hemostasis devices by gender. Pharmacoepidemiology and Drug Safety 2003; 12(3):237-241.

 

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

 

2009

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

 

Sex-based differences in the safety of drug-eluting stents containing bioresorbable materials - Dinesh Patwardhan, Ph.D., CDRH

 

2008

Workshop: Guidance for the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Devices - Kathryn O’Callaghan, CDRH 

  • Guidance developed: Draft Guidance for Industry and Food and Drug Administration Staff- Evaluation of Sex Differences in Medical Device Clinical Studies. Issued: December 19, 2011. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm283453.htm

     

Gender-Related Differences in QT Effects and Torsade de Pointes Potential of Drugs - Christine Garnett, PharmD/ Phillip Dinh, PhD, CDER

Publication from this project:

  • Dinh P, Sun J, Bai S, Kordzakhia G. Sex-Related Differences in QTc Effects Potential of Drugs. Rev Recent Clin Trials 2011; 6(3): 220-227.

 

2007

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, MD; Norman Stockbridge, MD, PhD, Duke Clinical Research Institute

Cardiac Safety Research Consortium (CSRC) Collaboration

  • Finkle J, Bloomfield D, Uhl K, Sanhai W, Stockbridge N, Krucoff MW. New precompetitive paradigms: Focus on cardiac safety. Cardiac Safety Research Consortium Conference Papers 2009.

 

Real-World Outcomes of Drug-Eluting Stents - Art Sedrakyan, MD, PhD, CDRH/AHRQ (07)

Publication from this project:

  • Douglas PS, Brennan JM, Anstrom KA, Sedrakyan A, Eisenstein EL, Haque G, Dai D, Kong DF, Hammill B, Curtis L, Matchar D, Brindis R, Peterson RD, Clinical Effectiveness of Coronary Stents in Elderly Persons - Results From 262,700 Medicare Patients in the American College of Cardiology–National Cardiovascular Data Registry, J Am C Cardiol 2009; 53(18):1629-41. 

      

Mechanisms of Gender Differences in Aspirin Effects: Metabolizing Enzymes and Therapeutic Targets - Baitang Ning, Ph.D., NCTR

 

The Impact of Sex-Based Differences in Atherosclerotic Plaque on the Response to Drug Eluting Stent Implantation - Dinesh Patwardhan, PhD, CDRH

Publication from this project:

2006

Evaluation of Availability and Quality of Information Available on Females Included in Mechanical device Implant Trials - Kathryn O'Callaghan, CDRH

 

ECG Warehouse - Mortara Instruments Inc., Justin Mortara, PhD, Mortara Instruments Inc.

Publication from this project:

  • Sarapa N, Mortara JL, Brown BD, Isola L,Badilini F. Quantitative performance of e-scribe warehouse in detecting quality issues with digital annotated ECG data from healthy subjects. J Clin Pharmacol 2008; 48:538-546.

      

ECG Warehouse - Duke Clinical Research Institute and Duke University - Christopher Cabell, M.D., MHS, Duke Clinical Research Institute (DCRI)

 

2005

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)

Publications from this project:

  • Shoaibi A, Tavris DR, McNulty S. Gender differences in correlates of troponin assay in diagnosis of myocardial infarction. Translational Research 2009; 154:250–256.

  • Tavris DR, Shoaibi A, Chen AY, Uchida T, Roe, Chen J. Gender differences in the treatment of non–ST-segment elevation myocardial infarction. Clin. Cardiol 2010; 33(2):99–103.

     

Systems Biology Approach to Evaluate Sex Differences in Heart of a Rat Model - James C. Fuscoe, Ph.D., NCTR

 

Implications of Gender-based Differences in Cardiovascular Disease on Imaging for Treatment and Diagnosis - Iacovos Kyprianou, Ph.D., CDRH

 

Use and Outcomes of Coronary Stents in Women: Use of a National Medicare Database - Karen Freund, MD, Boston Univ

Publication from this project:

  • Fruend KM, Jacobs AK, Pechacek JA, White HF, Ash AS. Disparities by Race, Ethnicity, and Sex in Treating Acute Coronary Syndromes. Journal of Women's Health 2012; 21(2): 126-131.

     

2004

Transmission Attenuation Correction for Female Patients Undergoing Myocardial Perfusion Imaging: Correction for Confounding Breast Tissue Artifact - Michelle Dew, MD, Univ. of Arizona

 

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

 

2003

Are Women at Higher risk from Proarrhythmic Drugs? - Jogarao Gobburu, PhD, CDER (03)

Publication from this project:

  • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). E14 Guidance on Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythic Potential for Non-Antiarrthmic Drugs 2005. Available from: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129357.pdf

     

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

 

Cardiovascular Effects Of Ultrasound Contrast Agents in Intact and Ovariectomized Female Animals - Melvin Stratmeyer, PhD, CDRH

 

Electrophysiological Characterization of Several Torsadogenic Drugs in Isolated Rabbit Hearts - John Koerner, PhD, CDER

Publication from this project:

  • Katchman AN, Koerner J, Tosaka T, Woosley RL, Ebert SN. Comparative evaluation of HERG currents and QT intervals following challenge with suspected torsadogenic and nontorsadogenic drugs. J Pharmacol Exp Ther. Epub 2006; 316:1098–1106.

      

2002

Pharmacokinetics and Pharmacodynamics (PK/PD) of Atenolol in Pregnancy - Mary Hebert, PharmD, University of Washington, Dept of Pharmacy

Publication from this project:

  • Eyal S, Kim JD, Anderson GD, et al. Atenolol Pharmacokinetics and Excretion in Breast Milk During the First 6 to 8 Months Postpartum. J Clin Pharmacol 2010; 50:1301-309

      

2001

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

 

Labetalol and Hypertension in Pregnancy: Pharmacokinetics and Pharmacodynamics - James Fischer, Ph.D. University of Illinois, Chicago

 

2000

Women's participation in clinical drug trials for unstable angina and myocardial infarction - Ann Farrell, MD, CDER (00)

 

Surveillance of Sex-specific Utilization, Morbidity, and Mortality Associated with Transmyocardial Revascularization- Ronald Kaczmarek, MD, MPH, CDRH (00)

Publication from this project:

  • Peterson ED, Kaul P, Kaczmarek RG, Hammill BG, Armstrong PW, Bridges CR, Ferguson TB. From controlled trials to clinical practice: monitoring transmyocardial revascularization use and outcomes. J Am Coll Cardiol 2003; 42(9):1611-6.

     

1998

Flow studies and the use of a waveguide in cardiovascular devices - Harvey Rudolf, PhD, CDRH

 

Ovarian steroids and cardiovascular disease: The role of gender in the effectiveness of interventional medical devices - James Karanian, PhD, CDRH

 

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)

Publication from this project:

  • Rodriguez J, Kilborn MJ, Liu, XK, Pezzullo JC, Woosley RL. Drug-Induced QT prolongation in women during the menstrual cycle. JAMA 2001; 285:1322-1326.

      

1994 -1997

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)

Publication from this project:

  • Rieves D, Wright G, Gupta G, Shacter E. Clinical Trial (GUSTO-1 and INJECT) Evidence of Earlier Death for Men than Women After Acute Myocardial Infarction. Am J Cardiol 2000; 85:147–153.

     

 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)

Publication from this project:

  • Benton RE, Sale M, Flockhart DA, Woosley RL. Greater quinidine-induced QTc interval prolongation in women. Clin Pharmacol Ther 2000; 67:413-8.

     

Terfenadine/Oral contraceptive study - Lou Cantillina, MD, CDER (94)