Cardiac Health, Mood, & Neuroimmune Activation

The study is designed to find out more about how mood and the nervous system affect the body's immune system. The investigators plan to study this in people who have been identified by their physician as being at-risk for the development of heart failure. There will be approximately 525 individuals participating in this study at UCSD and at the VASDHS. Individuals who will be asked to take part in this study will have a functional or structural heart problem apparent on an echocardiogram, or a previous heart attack, but no symptoms of heart failure. Some individuals will only complete one assessment (consisting of psychological questionnaires and interview, walk test, blood draw, and body measurements), whereas others deemed "high-risk" on the basis of a laboratory test, will be asked to complete that same assessment every 6 months for the duration of the study.

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Key information

Conditions

Heart Failure Behavior Behavioral Symptoms Cardiovascular Diseases Depression Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age range 18 years or older
ACC/AHA classification Stage B HF patients
Receiving optimal treatment according to their cardiologist and/or internists
An echocardiogram within the past 12 months
Ejection fraction: as described below in Initial Screening and Identification of Stage B Patients
Men and women of all ethnicities and races
Ability and physician clearance to perform mild exercise
With and without depressive symptoms and DSM-IV MDD
Ability to fully understand all elements of and sign the written informed consent before initiation of the study

Exclusion criteria

History of recent myocardial infarction (3 months)
Significant aortic or mitral stenosis, angina not adequately managed with nitrates
Coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 2 months
Hypertension >180/110 mm Hg
Recent stroke or significant cerebral neurological impairment
Severe COPD, patients who require mechanical ventilation, with cardiogenic shock, volume depletion
Subjects with high suicide risk
Immune-related disorders including infectious diseases and autoimmune and inflammatory disorders
Morbid Obesity: BMI > 40 due to likelihood of inability to perform exercise
Women who are pregnant or nursing
Major mental illness as determined by referring provider

Treatment and study plan

Primary outcomes

Rate of dysphoria

Time frame: up to 4 years

In high-risk (BNP ≥ 65pg/ml) Stage B patients, characterize rates of clinically significant depressed mood (BDI ≥10) and MDD (SCID) and determine prospective relationships with transition to Stages C and/or D HF and clinical outcomes during an average follow-up time of 30 months.

Secondary outcomes

Neuroimmune activation

Time frame: up to 4 years

In high-risk (BNP ≥ 65pg/ml) Stage B patients, characterize the role of neuroimmune activation (defined by circulating levels of C-reactive protein (CRP), Tumor Necrosis Factor-alpha (TNF-α), Interleukin (IL)-6, IL-1β, soluble intercellular adhesion molecule-1 (sICAM-1), soluble P-selectin (sP-selectin), norepinephrine, and functional leukocyte assays)in the relationship between clinically significant depressed mood and/or MDD and transition to symptomatic Stages C and/or D HF and clinical outcomes during an average follow-up time of 30 months.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

BNP and Neuroimmune Characteristics of CHF and Depression (Competing Renewal)

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Jun 8, 2012
Registry last updated: Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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