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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 17, 2005
    Last Updated
    August 5, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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