Cardiovascular Diseases Clinical Trial
Official title:
Training and Diastolic Function in Postmenopausal Women
This study is a prospective follow-up study to the Dose-Response to Exercise in Women (DREW) study. In DREW, 450 overweight, sedentary postmenopausal women were randomly assigned to either a non-exercise control group or to 1 of 3 weekly physical activity groups. The DREW study is evaluating the dose-response of exercise training in regard to changes in multiple cardiac risk factors. This study will measure diastolic heart function in a subset of the DREW population in order to examine the relationship between dose response, changes in physical activity, and diastolic function. Diastolic heart function will be assessed using both traditional and novel echocardiographic measures.
BACKGROUND:
Congestive heart failure (CHF) has become the number one reason for hospitalization in the
United States. Diastolic heart dysfunction is becoming increasingly recognized as a
significant factor in the etiology of CHF. Of the total affected population, 70% of patients
with diastolic heart failure are female, the majority of which are elderly. There is
currently no effective pharmacological therapy for the treatment of diastolic heart
dysfunction. Existing cross-sectional studies and limited training trials supporting the
hypothesis that exercise may improve diastolic function have only studied men. There is a
need for more properly controlled and adequately powered studies examining the effect of
exercise training on diastolic function, particularly in populations at high risk for CHF,
such as sedentary, postmenopausal women with elevated blood pressure.
DESIGN NARRATIVE:
A total of 215 sedentary, postmenopausal women at moderate risk for cardiovascular disease
will be randomly assigned to receive either exercise training or no exercise for six months.
This study will measure diastolic heart function using novel echocardiographic measurements,
such as pulmonary vein flow pattern, tissue Doppler, and color M-mode mitral inflow
propagation velocity. The study will also measure the left ventricular mass.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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