Status:
COMPLETED
Mechanisms of Erythropoietin Action in the Cardiorenal Syndrome
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Dutch Heart Foundation
Conditions:
Heart Failure, Congestive
Renal Insufficiency, Chronic
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 car...
Detailed Description
The combination of renal and cardiac failure is associated with an extraordinary cardiovascular morbidity and mortality. We propose that the severe cardiorenal syndrome (SCRS), the pathophysiological ...
Eligibility Criteria
Inclusion
- Patients with moderate renal failure (glomerular filtration rate \[GFR\] by Cockroft formula of 20-70 ml/min)
- Patients with heart failure NYHA class II-III-IV
- Hemoglobin (Hb) between 6.4 - 7.8 mmol/L in men and between 6.0 - 7.4 mmol/L in women
- Age \> 18 years, \< 80 years
- Written informed consent must be obtained from the subject or legally accepted representative before study-specific procedures, including screening procedures, are performed.
Exclusion
- Therapy within 1 year before randomisation or any planned erythropoietic therapy between randomisation and study day 1
- Known intolerance to EPO administration
- Previously suspected of or confirmed to have neutralizing antibodies to recombinant human erythropoietin (rHuEPO)
- Uncontrolled hypertension (RR \> 160 systolic, \>100 diastolic)
- Forms of secondary hypertension other than renal hypertension
- Uncontrolled diabetes (HbA1c \> 8.0 %)
- Primary dyslipidemia
- Kidney transplantation
- Proteinuria \> 3.5 g/L
- Acute renal failure or rapidly progressive glomerulonephritis
- Hyperparathyroidism (parathyroid hormone \[PTH\] \> 40)
- Bleeding or haemolysis as a cause of anaemia
- Deficiency of iron, folate, and/or vitamin B12
- Presence of chronic inflammatory disease or clinically significant infection
- Haematologic malignancy or solid tumour \< 5 years ago
- Chronic liver disease
- Haemoglobinopathies
- Alcohol and/or drug abuse
- Enrolment in another study
- Child bearing potential (pre-menopausal woman who is not using adequate contraceptive precautions)
- Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00356733
Start Date
January 1 2007
End Date
July 1 2011
Last Update
December 2 2011
Active Locations (2)
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1
Meander Medical Center Amersfoort
Amersfoort, Utrecht, Netherlands, 3800 BM
2
Univ. Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3508 GA