Epidemiology of Depression and Heart Failure in Aging
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Heart Failure
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00241761
First Posted
October 17, 2005
Last Updated
August 5, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00241761
Brief Title
Epidemiology of Depression and Heart Failure in Aging
Study Type
Observational
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To understand how depression leads to congestive heart failure (CHF) in older adults.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Heart Failure, Heart Failure, Congestive, Depression, Coronary Disease
7. Study Design
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Whooley
Organizational Affiliation
Northern California Institute for Res & Educ
12. IPD Sharing Statement
Learn more about this trial
Epidemiology of Depression and Heart Failure in Aging
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