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Ischemic CardiomyopathyPhase 4EPOHeartNCT00568542

Chronic, Low Dose Erythropoetin Beta in Ischemic Cardiomyopathy

A Phase 4 study testing erythropoetin beta in people with Ischemic Cardiomyopathy, run by Charite University, Berlin, Germany at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Ischemic Cardiomyopathy
What is being tested?
erythropoetin beta
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
2 sitesGermany
Study dates
May 2006to Oct 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charité Campus Buch

    Berlin, 13125

  • Charité Campus Virchow

    Berlin, 13353

Other trials in Germany

About this 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)

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.

Read the 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.

Being tested
erythropoetin beta, placebo
Keywords
cardiomyopathy, ischemia, percutaneous coronary intervention, remodeling
Medical subject headings
Cardiomyopathies, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erythropoetin betaDrug

    Also called NeoRecormom 10.000 I.E. Patronen Zul.Nr. EU/1/97/031/021-022

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

  • placeboDrug

    Also called Placebo to NeoRecormon 10.000 patron

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

Study groups in NCT00568542
Study groupRoleWhat they receive
1Active comparator35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months. The drug is self-administered.
Receives: Drug: erythropoetin beta
2Placebo comparatorPlacebo to erythropoetin beta.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (6)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves peak VO2 as measured by spiroergometry

    Measured: 6 months

  5. 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

    Measured: 6 months

  6. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2007 (estimated)
  2. Study startMay 2006
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00568542
Sponsor's protocol ID
8514077463
Other IDs
EudraCT number 2004-002646-35, EK 6 EA 3/015/05, KP-3910-4030711
Acronym
EPOHeart
Status last verified
Aug 2009
First submitted
5 Dec 2007
Last updated
4 Aug 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21505058

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing erythropoetin beta in people with Ischemic Cardiomyopathy, run by Charite University, Berlin, Germany at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00568542, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2009.

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