Viewing Study NCT00125476



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Last Modification Date: 2024-10-26 @ 9:13 AM
Study NCT ID: NCT00125476
Status: COMPLETED
Last Update Posted: 2006-10-11
First Post: 2005-07-29

Brief Title: Effects of Exercise Training on Diastolic Heart Function in Postmenopausal Women
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Heart Lung and Blood Institute NHLBI

Study Overview

Official Title: Training and Diastolic Function in Postmenopausal Women
Status: COMPLETED
Status Verified Date: 2006-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R21HL077165 NIH None httpsreporternihgovquickSearchR21HL077165