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Clinical Trials/NL-OMON33549
NL-OMON33549
Not yet recruiting
Phase 4

Myocardial perfusion and function in chronic heart failure patients treated with erythropoietin assessed by PET and MRI - REACH

Vrije Universiteit Medisch Centrum0 sites40 target enrollmentStarted: TBDLast updated:
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ConditionsHeart failureImpaired cardiac function10019280

Overview

Phase
Phase 4
Status
Not yet recruiting
Enrollment
40
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •\-Male and female patients \>\= 18 years of age.
  • •\-Congestive heart failure, NYHA II\-IV based on complaints of the patient at randomization, and a documented ejection fraction \<45%, as determined by echocardiography, CMR or nuclear imaging within 6 months prior to randomization.
  • •\-Anemia (Hb \< 10\.0 g/dL \[6\.2 mmol/L]), and normal serum iron concentration (serum iron \> 11 µmol/L ; ferritin \< 14 µG/L).
  • •\-Patients should be clinically stable: for \>\= 3 months: no addition or deletion of any new drug(s) to treat heart failure (dose changes will be allowed); and no hospitalization for heart failure \>\= 3 months prior to randomization.
  • •\-Written, informed consent.

Exclusion Criteria

  • •\-Known hypersensitivity to NeoRecormon or any of its components.
  • •\-Female patients of childbearing age not using an adequate method of contraception.
  • •\-Pregnancy.
  • •\-Participation in an Investigational Drug Trial in the last 6 months before randomization.
  • •\-Known non\-CHF\-related cause of anemia (additional internal medicine evaluation required, see later) including carcinoma, gastrointestinal bleeding focus, bone marrow dysfunction (for example anaplastic anemia), hypothyroidism, vitamin B12 deficiency, iron deficiency, folic acid depletion.
  • •\-Severe renal dysfunction, creatinin clearance \< 30 ml/min (according to Cockroft\-Gould formula) or serum creatinin \> 220 mmol/L (possible or definite renal indication for exogenous EPO administration).
  • •\-Scheduled revascularization procedures (PTCA, CABG) or CRT (cardiac resynchronization therapy), known at trial entry.
  • •\-Any other foreseeable indication for surgery within the trial period.
  • •\-Severe COPD (FEV1\<1\.0 liter).
  • •\-Uncontrolled hypertension (\>140/90 mmHg).

Investigators

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