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Journal of Cardiovascular Translational Research

Published in:

Open Access 01-09-2009

Using Basic Science to Design a Clinical Trial: Baseline Characteristics of Women Enrolled in the Kronos Early Estrogen Prevention Study (KEEPS)

Authors: V. M. Miller, D. M. Black, E. A. Brinton, M. J. Budoff, M. I. Cedars, H. N. Hodis, R. A. Lobo, J. E. Manson, G. R. Merriam, F. Naftolin, N. Santoro, H. S. Taylor, S. M. Harman

Published in: Journal of Cardiovascular Translational Research | Issue 3/2009

Abstract

Observational and epidemiological studies suggest that menopausal hormone therapy (MHT) reduces cardiovascular disease (CVD) risk. However, results from prospective trials showed neutral or adverse effects most likely due to differences in participant demographics, such as age, timing of initiation of treatment, and preexisting cardiovascular disease, which reflected in part the lack of basic science information on mechanisms of action of hormones on the vasculature at the time clinical trials were designed. The Kronos Early Estrogen Replacement Study (KEEPS) is a prospective, randomized, controlled trial designed, using findings from basic science studies, to test the hypothesis that MHT when initiated early in menopause reduces progression of atherosclerosis. KEEPS participants are younger, healthier, and within 3 years of menopause thus matching more closely demographics of women in prior observational and epidemiological studies than women in the Women’s Health Initiative hormone trials. KEEPS will provide information relevant to the critical timing hypothesis for MHT use in reducing risk for CVD.

It is from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and the NIH Roadmap for Medical Research. Contents of this paper are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH. Information on NCRR is available at http://www.ncrr.nih.gov/. Information on Reengineering the Clinical Research Enterprise can be obtained from http://nihroadmap.nih.gov.

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Title: Using Basic Science to Design a Clinical Trial: Baseline Characteristics of Women Enrolled in the Kronos Early Estrogen Prevention Study (KEEPS)
Authors: V. M. Miller
D. M. Black
E. A. Brinton
M. J. Budoff
M. I. Cedars
H. N. Hodis
R. A. Lobo
J. E. Manson
G. R. Merriam
F. Naftolin
N. Santoro
H. S. Taylor
S. M. Harman
Publication date: 01-09-2009
Publisher: Springer US
Published in: Journal of Cardiovascular Translational Research / Issue 3/2009
Print ISSN: 1937-5387
Electronic ISSN: 1937-5395
DOI: https://doi.org/10.1007/s12265-009-9104-y

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Using Basic Science to Design a Clinical Trial: Baseline Characteristics of Women Enrolled in the Kronos Early Estrogen Prevention Study (KEEPS)

Abstract

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Keynote webinar | Spotlight on sleep in brain health

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Abstract

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Other articles of this Issue 3/2009

Letter from the Guest Editors

Points to Consider: Genetic Evaluation of the Cardiology Patient

Women and Heart Disease: Neglected Directions for Future Research

Nutrition as a Vehicle for Cardiovascular Translational Research

17β-Estradiol Prevents Early-Stage Atherosclerosis in Estrogen Receptor-Alpha Deficient Female Mice

Outcomes of National Community Organization Cardiovascular Prevention Programs for High-Risk Women

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Year in Review: Heart failure and cardiomyopathies

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