Monocyte Phenotypic Changes in Heart Failure

NCT02997462 | Completed

• 1 other identifier: HUM00049322
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Decompensated Heart Failure

Keywords

Monocyte; Oxidative Stress; Endothelial Function; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Lys6c Hi and Lo, Mannose Receptor

  All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge)

• IL-10, IL-13

  All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge)

• Gene Expression (iNOS, CCL2, Ym1, Fizz, VEGF, MMP2/9)

  All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge)

• microRNA

  All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge)

• Monocyte/macrophage morphology

  All scheduled blood draws - hospital admission, discharge (3-14 days after admission), and first post-discharge appointment (5-10 days following discharge)

Study Arms (2)

Heart Failure

Heart Failure patients admitted to the ICU or Heart Failure Service. No changes in service-directed plan of care for patients.

Healthy Control

Healthy, age-matched controls.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure inpatients and age-matched controls

You may qualify if:

• 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.

You may not qualify if:

• 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
• \- Must be greater than or equal to 65 years of age
• Diabetes
• High blood pressure
• Active cancer
• Heart disease
• Lung disease
• Liver disease
• Kidney disease
• Active smoker

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (7)

• 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.

  PMID: 20565954 BACKGROUND

• 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.

  PMID: 15309701 BACKGROUND

• 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.

  PMID: 15611373 BACKGROUND

• 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.

  PMID: 2195340 BACKGROUND

• 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.

  PMID: 11319194 BACKGROUND

• 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.

  PMID: 15023878 BACKGROUND

• 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.

  PMID: 10072227 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for cytokine measures Blood samples for monocyte cell surface marker and functional phenotyping

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Scott Hummel, MD MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Adam Stein, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Sascha Goonewardena, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: December 20, 2016
• Study Start: November 1, 2011
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)