Primary:Comparing EPO induced proliferation, G2/G0 ratio, and apoptosis of UT7-EPO cells between anemic and non-anemic CHF patients. Secondary:1. Comparing the levels of several circulating inhibitory factors (TNF-alpha, TGF-Beta, Ac-SDKP, INF-gamma…
ID
Source
Brief title
Condition
- Anaemias nonhaemolytic and marrow depression
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in proliferation, G2/G0 ratio and numbers of apoptotic cells after
EPO-stimulation of UT7-EPO cells after 3 days in culture.
Secondary outcome
•Difference between anaemic and non-anaemic CHF patients in plasma
ACE-activity, Ac-SDKP, EPO, high-sensitivity CRP, IFN-gamma, IL-1, and
TNF-alpha levels.
•Correlation between UT7-EPO cell proliferation and plasma ACE-activity,
Ac-SDKP, EPO, high-sensitivity CRP, IFN-gamma, IL-1, and TNF-alpha levels.
•Difference in proliferation between untreated and inhibitory antibody
pre-treated serum
Background summary
Anemie is associated with increased mortalitiy in chronic heart failure (CHF)
patient. Recent work from our group demonstrated that the serum of anemic heart
failure patients has inhibitory effects on erythropoiesis. The current project
aims to elucidate the mechanism of inhibition and the substrate responsible.
Study objective
Primary:
Comparing EPO induced proliferation, G2/G0 ratio, and apoptosis of UT7-EPO
cells between anemic and non-anemic CHF patients.
Secondary:
1. Comparing the levels of several circulating inhibitory factors (TNF-alpha,
TGF-Beta, Ac-SDKP, INF-gamma) in anemic and non-anemic CHF patients.
2. Evaluate the change in proliferation after serum pre-treatment with
neutralising antibodies directed against different inhibitory factors.
Study design
Single centre, investigator initiated cross sectional study. Sample size: 40
patients. UT7 EPO dependant cell line was kindly provided by prof. E. Vellenga.
40 cc blood will be collected, and stored as serum and plasma (Heparin and
EDTA).
Study burden and risks
Burses, pain and infection of skin due to venapunction is a risk associated
with participation.
Hanzeplein 1
9700RB, Groningen
Nederland
Hanzeplein 1
9700RB, Groningen
Nederland
Listed location countries
Age
Inclusion criteria
a. Male or female
b. Between 50-90 years of age
c. Willing to provide written informed consent
Exclusion criteria
f. Unstable medical condition
g. Presence of other serious medical conditions
h. Renal failure (kreatinin > 150 µmol/l)
i. Concomitant inflammatory or malignant disease
j. *Wilsonbekwaamheid*
k. Chronic steroid use
l. Recent blood transfusion
m. Currently receiving EPO-treatment
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL13317.042.06 |