Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention

  • Lan Shen
  • Chiara MelloniEmail author
Women + Heart Disease (J Robinson, Section Editor)
Part of the following topical collections:
  1. Topical Collection on Women and Heart Disease


Cardiovascular disease (CVD) is the leading cause of mortality in women. Differences in pathophysiology, diagnosis, and treatment of women with cardiovascular disease compared with men have become a major focus during the past decades. Guideline of CVD prevention in women drew heavily on the results of randomized clinical trials (RCT). However, data from RCT in women was limited, leading to concerns of women been underrepresented in clinical trials from which guidelines were generated. During the past several years, researchers, physicians, and regulators have made substantial efforts to improve understanding of the sex difference in CVD and to recognize the importance of heart disease in women. The purpose of this review is to evaluate contemporary sex differences in CVD disease management, current representation of women in RCT, and examine factors that may improve women’s representation and quality of care in CVD prevention in women.


Cardiovascular disease Women Randomized clinical trial 


Compliance with Ethics Guidelines

Conflict of Interest

Chiara Melloni declares no conflicts of interest. Lan Shen declares no conflicts of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by the author.


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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  1. 1.Department of CardiologyShanghai Renji HospitalShanghaiChina
  2. 2.Duke Clinical Research InstituteDuke University Medical CenterDurhamUSA

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