Cardiac Health, Mood, & Neuroimmune Activation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Paul J. Mills, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01615094
First received: June 6, 2012
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition
Heart Failure
Depression

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 University of California, San Diego:

Primary Outcome Measures:
  • Rate of dysphoria [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

blood


Estimated Enrollment: 522
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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 ClinicalTrials.gov identifier: NCT01615094

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

No publications provided

Responsible Party: Paul J. Mills, Professor IR, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01615094     History of Changes
Other Study ID Numbers: 5 R01 HL073355-06
Study First Received: June 6, 2012
Last Updated: June 7, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Heart Failure
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014