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NCT00241761 Clinical Trial

Epidemiology of Depression and Heart Failure in Aging

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00241761
Other study ID # 1312
Secondary ID R01HL079235-04
Status Completed
Phase N/A
First received October 17, 2005
Last updated August 5, 2016
Start date September 2005
Est. completion date August 2010

Study information
Verified date April 2012
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To understand how depression leads to congestive heart failure (CHF) in older adults.

Description:

BACKGROUND:

Depression is known to be associated with an increased risk of coronary heart disease (CHD), and with adverse outcomes among older adults with CHD. Recent evidence suggests that depression is also associated with an increased risk of congestive heart failure, and with adverse outcomes among older adults with congestive heart failure. However, the mechanisms by which depression leads to congestive heart failure are not known

DESIGN NARRATIVE:

To determine the mechanisms of association between depression and CHF, the investigators will use an existing cohort of 1024 older adults (mean age 67) with CHD (including 680 with no heart failure and 344 with clinical or subclinical heart failure) who were recruited between September 2000 and December 2002 for "The Heart and Soul Study." The Heart and Soul Study was originally designed to understand the mechanism of association between depression and CHD. Since patients with CHD are at high risk for CHF, this well-characterized cohort will provide a unique opportunity to examine the relation between depression and CHF. At baseline, participants completed a depression interview (Diagnostic Interview Schedule); full exercise treadmill testing with stress echocardiography; 24-hour Holter monitoring for heart rate variability; 24-hour urine collection for cortisol and norepinephrine; venous blood measurements for lipids, platelet reactivity, and C-reactive protein; and an extensive questionnaire. Participants have been followed annually by telephone. The investigators will invite all participants to return for a 5-year examination, and will follow them for an additional 3 years thereafter, to determine (a) the independent association between baseline depression and CHF, and (b) the extent to which 5-vear changes in biological and behavioral factors associated with depression explain the relation between depression and CHF. By identifying the mechanisms that explain the relation between depression and CHF, this study will enable them to target specific areas for improving the treatment of these patients.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date August 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
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