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CompletedNCT01615094Updated Mar 19, 2015

Cardiac Health, Mood, & Neuroimmune Activation

An observational study in Heart Failure and Depression, sponsored by University of California, San Diego. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-19.

Sponsored by University of California, San Diego · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
456
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Heart Failure
  • Depression

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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 456 is above the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
456 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Rate of dysphoria

    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.

    Time frame: up to 4 years

Secondary outcomes

  1. Neuroimmune activation

    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.

    Time frame: up to 4 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Redwine LS, Henry BL, Pung MA, Wilson K, Chinh K, Knight B, Jain S, Rutledge T, Greenberg B, Maisel A, Mills PJ. Pilot Randomized Study of a Gratitude Journaling Intervention on Heart Rate Variability and Inflammatory Biomarkers in Patients With Stage B Heart Failure. Psychosom Med. 2016 Jul-Aug;78(6):667-76. doi: 10.1097/PSY.0000000000000316. PubMed 27187845 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01615094
Lead sponsor
University of California, San Diego
Responsible party
Paul J. Mills (Professor IR, University of California, San Diego) — Principal investigator
First posted
Jun 8, 2012
Start date
Jan 2011
Primary completion
Nov 2014
Completion
Feb 2015
Last update
Mar 19, 2015

Study contacts

Paul J Mills, PhD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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