Chronic, Low Dose Erythropoetin Beta in Ischemic Cardiomyopathy (EPOHeart)

August 3, 2009 updated by: Charite University, Berlin, Germany

Pilot Study to Assess the Effect of Low Dose Epoetin Beta Administered for Six Month in Patients With Ischemic Heart Failure Subjected to Percutaneous Coronary Intervention (PCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charite Campus Virchow
      • Berlin, Germany, 13125
        • Charite Campus Buch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • successful coronary intervention < 14 days
  • regional contraction deficit of the left ventricle as detected either by echocardiography or cardiacMRI
  • globally reduced ejection fraction (cardiac MRI or echocardiography: < 60%)
  • willing and able to cooperate
  • voluntary participation

Exclusion Criteria:

  • contraindication for cardiac MRI (i.e. pacemaker, ICD current or within the next 6 months, other metal implants)
  • cardiogenic shock at time of inclusion
  • uncontrolled hypertension (systolic blood pressure > 180mmHg)
  • hemoglobin > 16mg/dl
  • thrombocytosis
  • malignant tumor
  • missing informed consent
  • renal failure (creatinine > 300 mg/dl)
  • liver failure
  • other prognosis limiting, severe diseases (i.e. dementia)
  • indication for open label erythropoietin treatment
  • allergy towards solvents of the EPO preparation
  • woman of childbearing potential
  • other clinical study within the preceding 30days
  • known alcohol or drug abuse
  • neurologic or psychiatry disorders
  • previous organ transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months. The drug is self-administered.
Drug: erythropoetin beta
35 I.E. kg body weight subcutaneous once per week for 6 months
Other Names:
  • NeoRecormom 10.000 I.E. Patronen Zul.Nr. EU/1/97/031/021-022
Placebo Comparator: 2
Placebo to erythropoetin beta.
Drug: placebo
35 I.E. kg body weight placebo to erythropoetin beta
Other Names:
  • Placebo to NeoRecormon 10.000 patron

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The application of 35 I.E./kg body weight erythropoetin beta s.c. once per week for 6 months is well tolerated and safe in patients after PCI.
Time Frame: 6 months
6 months
35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves left ventricular regional wall motion as assessed by cardiac MRI.
Time Frame: 6 months
6 months
35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months reduces serum levels of brain natriuretic peptide as a measure of heart failure.
Time Frame: 6 months
6 months
35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves peak VO2 as measured by spiroergometry
Time Frame: 6 months
6 months
35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves measures or cardiac diastolic dysfunction as assessed by echocardiography
Time Frame: 6 months
6 months
35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves cardiac tissue texture aqs assessed by contrast-enhanced cardiac MRI
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Martin W Bergmann, MD, Charité Camous Buch, University Medicine Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

December 5, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimate)

December 6, 2007

Study Record Updates

Last Update Posted (Estimate)

August 4, 2009

Last Update Submitted That Met QC Criteria

August 3, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8514077463
  • EudraCT number 2004-002646-35
  • EK 6 EA 3/015/05
  • KP-3910-4030711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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