- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01615094
Cardiac Health, Mood, & Neuroimmune Activation
17. marts 2015 opdateret af: Paul J. Mills, University of California, San Diego
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
456
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
American College of Cardiology/American Heart Association (ACC/AHA) asymptomatic Stage B patients with B-Type natriuretic peptide (BNP) ≥ 65pg/ml
Beskrivelse
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rate of dysphoria
Tidsramme: 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.
|
up to 4 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Neuroimmune activation
Tidsramme: 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.
|
up to 4 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Paul J Mills, PhD, University of California, San Diego
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2011
Primær færdiggørelse (Faktiske)
1. november 2014
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
6. juni 2012
Først indsendt, der opfyldte QC-kriterier
7. juni 2012
Først opslået (Skøn)
8. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. marts 2015
Sidst verificeret
1. marts 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5R01HL073355-06 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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