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Intramyocardial injections of erythropoietin-analogue C.E.R.A. in ischemic cardiomyopathy: the ALSTER C.E.R.A. trial


Journal of Cardiology & Current Research
Christina Paitazoglou,1,2 Martin W Bergmann,1 Denis Losik,3 Evgeny Pokushalov,3 Vitaly Shabanov,3 Alexander Romanov3

Abstract

Objectives: Erythropoietin (EPO) improved cardiac regeneration in experimental models
of ischemic heart disease. A pilot trial found subcutaneously administered EPO to improve
surrogate markers of left ventricular (LV) function in ischemic cardiomyopathy. This
clinical study tests the feasibility and safety of the intramyocardial delivery route of a long-
acting EPO-analogue (C.E.R.A.) in patients with ischemic cardiomyopathy.
Methods: The ALSTER C.E.R.A. trial was a Phase II, open label, 1:1 randomized, single-
center study testing intramyocardial injections of long-acting EPO analogue C.E.R.A.
(C.E.R.A. NOGA: once 180 μg) using the NOGA XP system versus the subcutaneous
application (C.E.R.A. SC: 30μg s.c./month for 6 months) in 59 symptomatic chronic heart
failure (HF) patients with impaired LV function (ejection fraction (EF) ≤ 45%).
Results: Follow-up up to three years with both clinical and imaging endpoints found
intramyocardial delivery of C.E.R.A. to be feasible, safe and to possibly attenuate LV
remodeling. Patients in the C.E.R.A. NOGA group showed stable parameter for LV end-
diastolic diameter and volume (LVEDD and LVEDV), while C.E.R.A. SC patients had
significant dilation of the LV (C.E.R.A. NOGA vs. SC, mean standard error of the mean:
?LVEDD 0.02±0.1mm, p=0.8 vs. 0.3±0.09mm, p=0.0026; ?LVEDV 10±15.9ml, p=0.5 vs.
34.8±11.3ml, p=0.0081; ?EF 2.4±1.2%, p=0.045 vs. -1.6±1.1, p=0.1 respectively). NYHA
class significantly improved and the hospitalization rate was numerically reduced in the
C.E.R.A. NOGA group, while three-year mortality was identical.
Conclusions: Intramyocardial injection of C.E.R.A. is feasible, safe and possibly attenuates
LV remodeling in ischemic HF patients with LV dysfunction compared to the systemic
application.

Keywords

heart failure, ischemic cardiomyopathy, erythropoietin, cardiac regeneration

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