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Cardiac Health, Mood, & Neuroimmune Activation

This study has been completed.
Information provided by (Responsible Party):
Paul J. Mills, University of California, San Diego Identifier:
First received: June 6, 2012
Last updated: March 17, 2015
Last verified: March 2015
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.

Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BNP and Neuroimmune Characteristics of CHF and Depression (Competing Renewal)

Resource links provided by NLM:

Further study details as provided by Paul J. Mills, University of California, San Diego:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Biospecimen Retention:   Samples With DNA

Enrollment: 456
Study Start Date: January 2011
Study Completion Date: February 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
High-risk Stage B Heart Failure Patients
American College of Cardiology/American Heart Association (ACC/AHA) asymptomatic Stage B patients with B-Type natriuretic peptide (BNP) ≥ 65pg/ml


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
American College of Cardiology/American Heart Association (ACC/AHA) asymptomatic Stage B patients with B-Type natriuretic peptide (BNP) ≥ 65pg/ml

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of recent myocardial infarction (3 months)
  2. Significant aortic or mitral stenosis, angina not adequately managed with nitrates
  3. Coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 2 months
  4. Hypertension >180/110 mm Hg
  5. Recent stroke or significant cerebral neurological impairment
  6. Severe COPD, patients who require mechanical ventilation, with cardiogenic shock, volume depletion
  7. Subjects with high suicide risk
  8. Immune-related disorders including infectious diseases and autoimmune and inflammatory disorders
  9. Morbid Obesity: BMI > 40 due to likelihood of inability to perform exercise
  10. Women who are pregnant or nursing
  11. Major mental illness as determined by referring provider
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01615094

Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Paul J Mills, PhD University of California, San Diego
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paul J. Mills, Professor IR, University of California, San Diego Identifier: NCT01615094     History of Changes
Other Study ID Numbers: 5R01HL073355-06 ( US NIH Grant/Contract Award Number )
Study First Received: June 6, 2012
Last Updated: March 17, 2015

Additional relevant MeSH terms:
Depressive Disorder
Heart Failure
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases processed this record on May 25, 2017