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Chronic, Low Dose Erythropoetin Beta in Ischemic Cardiomyopathy (EPOHeart)
This study is currently recruiting participants.
Verified by Charite University, Berlin, Germany, May 2008
First Received: December 5, 2007   Last Updated: May 7, 2008   History of Changes
Sponsored by: Charite University, Berlin, Germany
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00568542
  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 IV

MedlinePlus related topics: Cardiomyopathy Heart Failure
Drug Information available for: Erythropoietin Epoetin alfa Epoetin beta
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

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 ]

Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months.
Drug: erythropoetin beta
35 I.E. kg body weight subcutaneous once per week for 6 months
2: Placebo Comparator
Placebo to erythropoetin beta.
Drug: placebo
35 I.E. kg body weight placebo to erythropoetin beta

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

Contacts
Contact: Martin W Bergmann, MD 49-309-401 ext 12916 martin.bergmann@charite.de
Contact: Heidrun Mehling, MD 49-309-417 ext 2221 heidrun.mehling@charite.de

Locations
Germany
Charité Campus Buch Recruiting
Berlin, Germany, 13125
Contact: Sibylle Schmidt, study nurse     49-9401 ext 12910     sibylle.schmidt@charite.de    
Contact: Angelika Weber, secretary     49-309-401 ext 52950     angelika-weber@helios-kliniken.de    
Sub-Investigator: Heidrun Mehling, MD            
Sub-Investigator: Jens Jordan, MD            
Charité Campus Virchow Active, not recruiting
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: Charité Campus Buch, University Medicine Berlin, Germany ( Priv.-Doz. Dr. Martin W. Bergmann )
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: May 7, 2008
ClinicalTrials.gov Identifier: NCT00568542     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Epoetin Alfa
Heart Failure
Heart Diseases
Hematinics
Ischemia
Cardiomyopathies

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

ClinicalTrials.gov processed this record on May 06, 2009