Heart FailureNCT01615094
Cardiac Health, Mood, & Neuroimmune Activation
An observational study of Heart Failure and Depression, run by University of California, San Diego.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Depression
- How many people
- 456 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: American College of Cardiology/American Heart Association (ACC/AHA) asymptomatic Stage B patients with B-Type natriuretic peptide (BNP) ≥ 65pg/ml
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: BNP and Neuroimmune Characteristics of CHF and Depression (Competing Renewal)
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.
- Conditions
- Heart Failure, Depression
- Medical subject headings
- Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul J. Mills, University of California, San Diego
- Investigators
- Paul J Mills, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615094
- Sponsor's protocol ID
- 5R01HL073355-06
- Status last verified
- Mar 2015
- First submitted
- 6 Jun 2012
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BNP and Neuroimmune Characteristics of CHF and Depression (Competing Renewal)
- ClinicalTrials.gov ID
- NCT01615094
- Acronym / sponsor ID
- 5R01HL073355-06
- Conditions
- Heart Failure, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- American College of Cardiology/American Heart Association (ACC/AHA) asymptomatic Stage B patients with B-Type natriuretic peptide (BNP) ≥ 65pg/ml
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Neuroimmune activation
Time frame: up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Derived from this study: PubMed 27187845Redwine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Mills, PhD principal investigator
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Depression, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dysphoria (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01615094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.