NCT00568542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2006

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

2.4 years

First QC Date

December 5, 2007

Last Update Submit

August 3, 2009

Conditions

Ischemic Cardiomyopathy

Keywords

cardiomyopathyischemiapercutaneous coronary interventionremodeling

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (6)

  • 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.

    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.

    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.

    6 months

  • 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves peak VO2 as measured by spiroergometry

    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

    6 months

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months. The drug is self-administered.

Drug: erythropoetin beta

2

PLACEBO COMPARATOR

Placebo to erythropoetin beta.

Drug: placebo

Interventions

erythropoetin betaDRUG

35 I.E. kg body weight subcutaneous once per week for 6 months

Also known as: NeoRecormom 10.000 I.E. Patronen Zul.Nr. EU/1/97/031/021-022
1
placeboDRUG

35 I.E. kg body weight placebo to erythropoetin beta

Also known as: Placebo to NeoRecormon 10.000 patron
2

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • contraindication for cardiac MRI (i.e. pacemaker, ICD current or within the next 6 months, other metal implants)
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité Campus Buch

Berlin, 13125, Germany

Location

Charité Campus Virchow

Berlin, 13353, Germany

Location

Related Publications (1)

  • Bergmann MW, Haufe S, von Knobelsdorff-Brenkenhoff F, Mehling H, Wassmuth R, Munch I, Busjahn A, Schulz-Menger J, Jordan J, Luft FC, Dietz R. A pilot study of chronic, low-dose epoetin-beta following percutaneous coronary intervention suggests safety, feasibility, and efficacy in patients with symptomatic ischaemic heart failure. Eur J Heart Fail. 2011 May;13(5):560-8. doi: 10.1093/eurjhf/hfr002.

    PMID: 21505058DERIVED

MeSH Terms

Conditions

CardiomyopathiesIschemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin W Bergmann, MD

    Charité Camous Buch, University Medicine Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

May 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

DE(2)