Heart Failure Clinical Trial
Official title:
Monocyte Phenotypic Changes in Heart Failure
NCT number | NCT02997462 |
Other study ID # | HUM00049322 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2011 |
Est. completion date | June 23, 2022 |
Verified date | May 2024 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
There are many treatments that can improve how long and how well people live with heart failure when they are outside the hospital. However, the investigators know less about how to effectively treat hospitalized heart failure patients so that they do not have to return to the hospital after they go home. Part of the problem is that the investigators don't understand all of the causes of worsening heart failure. Previous studies by other researchers suggest that white blood cells called monocytes are over-active in heart failure. Under normal conditions monocytes help fight infections in the body, but over-active monocytes release chemicals that could cause abnormal function of the heart and blood vessels. The investigators' research group believes that over-active monocytes may be an important reason that heart failure worsens before hospitalization. In this study the investigators will collect blood samples on the day a patient comes into the hospital, the day they return home, and the day they come back to the clinic for a follow-up appointment. The investigators will measure the inflammation in the bloodstream and the activity of monocytes from the patients' blood to see if there are changes in these measurements as heart failure improves. The investigators will also call each patient several times after they return home to ask questions about how they are doing.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 23, 2022 |
Est. primary completion date | June 23, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Heart Failure Patients: - 18 years of age or older - Patients must be diagnosed with heart failure - Patients must be hospitalized at the University of Michigan Hospital for treatment of heart failure symptoms. Exclusion Criteria: Heart Failure Patients: - Heart attack or other active problem with coronary artery disease - Severe kidney failure or need for dialysis - An active infection or inflammatory condition - A need for treatment that affects the immune system (e.g. systemic steroids, immunomodulatory therapies) - A planned surgery during this hospital admission, including heart transplant or other heart surgery Inclusion Criteria: Healthy Control Patients: - Must be greater than or equal to 65 years of age Exclusion Criteria: Healthy Control Patients: - Diabetes - High blood pressure - Active cancer - Heart disease - Lung disease - Liver disease - Kidney disease - Active smoker |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Aukrust P, Ueland T, Lien E, Bendtzen K, Muller F, Andreassen AK, Nordoy I, Aass H, Espevik T, Simonsen S, Froland SS, Gullestad L. Cytokine network in congestive heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol. 1999 Feb 1;83(3):376-82. doi: 10.1016/s0002-9149(98)00872-8. — View Citation
Colombo PC, Banchs JE, Celaj S, Talreja A, Lachmann J, Malla S, DuBois NB, Ashton AW, Latif F, Jorde UP, Ware JA, LeJemtel TH. Endothelial cell activation in patients with decompensated heart failure. Circulation. 2005 Jan 4;111(1):58-62. doi: 10.1161/01.CIR.0000151611.89232.3B. Epub 2004 Dec 20. — View Citation
Deswal A, Petersen NJ, Feldman AM, Young JB, White BG, Mann DL. Cytokines and cytokine receptors in advanced heart failure: an analysis of the cytokine database from the Vesnarinone trial (VEST). Circulation. 2001 Apr 24;103(16):2055-9. doi: 10.1161/01.cir.103.16.2055. — View Citation
Levine B, Kalman J, Mayer L, Fillit HM, Packer M. Elevated circulating levels of tumor necrosis factor in severe chronic heart failure. N Engl J Med. 1990 Jul 26;323(4):236-41. doi: 10.1056/NEJM199007263230405. — View Citation
Mann DL, McMurray JJ, Packer M, Swedberg K, Borer JS, Colucci WS, Djian J, Drexler H, Feldman A, Kober L, Krum H, Liu P, Nieminen M, Tavazzi L, van Veldhuisen DJ, Waldenstrom A, Warren M, Westheim A, Zannad F, Fleming T. Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL). Circulation. 2004 Apr 6;109(13):1594-602. doi: 10.1161/01.CIR.0000124490.27666.B2. Epub 2004 Mar 15. — View Citation
Polidori MC, Pratico D, Savino K, Rokach J, Stahl W, Mecocci P. Increased F2 isoprostane plasma levels in patients with congestive heart failure are correlated with antioxidant status and disease severity. J Card Fail. 2004 Aug;10(4):334-8. doi: 10.1016/j.cardfail.2003.11.004. — View Citation
Seidler S, Zimmermann HW, Bartneck M, Trautwein C, Tacke F. Age-dependent alterations of monocyte subsets and monocyte-related chemokine pathways in healthy adults. BMC Immunol. 2010 Jun 21;11:30. doi: 10.1186/1471-2172-11-30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in IL-6 between hospital admission and discharge | Cytokine | All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge) | |
Secondary | Lys6c Hi and Lo, Mannose Receptor | Cell Surface Markers | All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge) | |
Secondary | IL-10, IL-13 | Cytokine | All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge) | |
Secondary | Gene Expression (iNOS, CCL2, Ym1, Fizz, VEGF, MMP2/9) | Monocyte gene expression | All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge) | |
Secondary | microRNA | miR155, let7, mir-33a | All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge) | |
Secondary | Monocyte/macrophage morphology | Macrophages/monocytes will be classified based on their morphology | All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge) | |
Secondary | Serum F-2 Isoprostanes | Oxidative stress marker | All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge) | |
Secondary | TNF-alpha | Marker of inflammation | All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge) |
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