We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Cardiac Health, Mood, & Neuroimmune Activation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01615094
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Heart Failure Depression

Study Design

Study Type : Observational
Actual Enrollment : 456 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BNP and Neuroimmune Characteristics of CHF and Depression (Competing Renewal)
Study Start Date : January 2011
Primary Completion Date : November 2014
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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
blood

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615094


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul J. Mills, Professor IR, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01615094     History of Changes
Other Study ID Numbers: 5R01HL073355-06 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

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