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Mechanisms of Erythropoietin Action in the Cardiorenal Syndrome

NCT00356733 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2011-12-02

No results posted yet for this study

Summary

Erythropoietin (EPO) treatment in patients with the severe cardiorenal syndrome increases cardiac performance and decreases progression of renal failure by dampening the main driving forces of the cardiorenal syndrome in part via non-erythropoietic pathways.

I. Does EPO administration to patients with the severe cardiorenal syndrome increase cardiac performance and decrease progression of renal disease?

II. Does EPO treatment affect the main driving forces of the cardiorenal connection, that is, dampen the activated renin-angiotensin system (RAS), attenuate increased reactive oxygen species (ROS), normalize increased sympathetic activity, and decrease inflammation?

III. Does EPO treatment positively affect the cell function of patients with the cardiorenal syndrome:

1. are gene expression signatures of leukocytes positively influenced by EPO treatment,
2. does EPO shift the Jak/STAT pathway to a less pro-inflammatory profile in monocytes, and
3. are function and number of endothelial progenitor cells (EPCs) affected by treatment with EPO in the cardiorenal syndrome?

IV. Can the direct actions of EPO be differentiated from the effects on hemoglobin levels?

Conditions

  • Heart Failure, Congestive
  • Renal Insufficiency, Chronic

Interventions

DRUG

Erythropoietin administration

50 IU/kg/week EPO to a target haemoglobin level of 13.7 g/dL for men and 13.4 g/dL for women (group A) or to a target comparable to starting hemoglobin level (group B)

Sponsors & Collaborators

  • Dutch Heart Foundation

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Branko Braam, MD, PhD · UMC Utrecht, The Netherlands

  • Carlo AJ Gaillard, MD, PhD · Meander Medical Center Amersfoort, The Netherlands

  • Pieter AF Doevendans, MD, PhD · UMC Utrecht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00356733 on ClinicalTrials.gov