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P021

Peptide 021, GLXC-21260

Quick Stats
Studies 37
Trials 57
Completed PHASE4 INTERVENTIONAL NCT00568542

Chronic, Low Dose Erythropoetin Beta in Ischemic Cardiomyopathy

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The study is testing the hypothesis, that the application of low dose erythropoetin beta (35 I.E./kg BW/week) for 6 months following successful coronary revascularization by PCI improves left ventricular remodeling as assessed by cardiac MRI.

Detailed Description

Several effects known to be exerted by erythropoetin (EPO) directly in the heart independent of hemoglobin levels could be of value immediately after revascularization procedures in ischemic cardiac remodeling: the generation of new capillaries is enhanced by the mobilization of endothelial progenitor cells from the bone marrow. EPO is neuron- and cardio-protective after ischemia/reperfusion. Administration of EPO enhances neuronal progenitors to differentiate into functional neurons; this observation may also be valid for the cardiac compartment. The concept of organ-specific effects of EPO independent of hemoglobin levels is supported by the analysis of EPO analogues lacking hematopoietic activity. In humans, currently this concept can only be tested by the use of EPO-doses that do not affect hemoglobin levels. The concept is valid as clinical trials have been performed showing that doses as low as 5000 I.U. EPO once weekly increase the levels of endothelial progenitor cells in blood. On the other hand, recent clinical trials have also shown neutral or even deleterious effects of high dose EPO treatment raising hemoglobin levels to above 12mg/dl in pre-dialysis patients concerning cardiovascular endpoints. Therefore, the chronic, hemoglobin-neutral administration of low doses of EPO might be a successful approach concerning ischemic cardiomyopathy. Study outline: This investigator initiated, double-blind, placebo-controlled study is testing the hypothesis, that low doses of erythropoietin beta (35 I.U./kg body weight) started within 14 days after a successful percutaneous coronary intervention enhance left ventricular remodeling as determined by comparison of two cardiac MRI´s over a course of 6 months. Secondary endpoints include changes in diastolic dysfunction as measured by echocardiography, VO2 measured by spiroergometry and serum brain natriuretic peptide levels.

Interventions

Name: erythropoetin beta
Type: DRUG
Description: 35 I.E. kg body weight subcutaneous once per week for 6 months
Name: placebo
Type: DRUG
Description: 35 I.E. kg body weight placebo to erythropoetin beta

Primary Outcomes

Measure: Change in global left ventricular ejection fraction between initial examination at study entry and the 6 months follow up examination employing cardiac MRI
TimeFrame: 6 months
Description:

Trial Information

NCT ID

NCT00568542

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Charite University, Berlin, Germany

Last Updated

December 15, 2025