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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00568542
First received: December 5, 2007
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Ischemic Cardiomyopathy
Drug: erythropoetin beta
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo to NeoRecormon 10.000 patron

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568542

Locations
Germany
Charité Campus Buch
Berlin, Germany, 13125
Charité Campus Virchow
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Martin W Bergmann, MD Charité Camous Buch, University Medicine Berlin, Germany
  More Information

No publications provided

Responsible Party: Priv.-Doz. Dr. Martin W. Bergmann, Charité Campus Buch, University Medicine Berlin, Germany
ClinicalTrials.gov Identifier: NCT00568542     History of Changes
Other Study ID Numbers: 8514077463, EudraCT number 2004-002646-35, EK 6 EA 3/015/05, KP-3910-4030711
Study First Received: December 5, 2007
Last Updated: August 3, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
cardiomyopathy
ischemia
percutaneous coronary intervention
remodeling

Additional relevant MeSH terms:
Ischemia
Cardiomyopathies
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014