Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement (EPICURE)

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Status and phase: Completed; Phase 3

Conditions: Anemia; Aortic Stenosis

Treatments: Drug: Erythropoietin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02390102

EPICURE

CER-20809 (Other Identifier)

Details and patient eligibility

About

The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis undergoing transcatheter aortic valve replacement.

Full description

STUDY DESIGN

Prospective randomized double blind study including patients diagnosed with severe symptomatic aortic stenosis and anemia undergoing aortic valve replacement. The patients will be identified in the cardiac surgery / aortic stenosis outpatient clinic or in the hospitalization department of the Institut Universitaire de Cardiologie et de Pneumologie de Quebec.

SAMPLE SIZE

100 patients (50 patients per group).

Enrollment: 117 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥60-year old

2. Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention

3. Anemia defined according to the World Health Organization (WHO) definition 69:

   1. Men: Hemoglobin<130 g/L
   2. Women: <120 g/L

Exclusion criteria

1. Contraindication for transcatheter aortic valve replacement.
2. Erythropoietin treatment within last 30 days before Aortic Valve Replacement
3. Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement
4. Ferritin>800 µg/L
5. Uncontrolled hypertension (Blood pressure>175/95 )
6. Platelet count>450,000/L
7. Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days)
8. Dialysis patients
9. Hemodynamic instability as defined as the need of hemodynamic support with inotropic drugs, intraortic balloon pump counter-pulsation or left ventricular assist device before index procedure
10. Active cancer or very high risk of thromboembolic events
11. Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy
12. No written consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

Erythropoietin

Active Comparator group

Description:

Dose: darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose Administered at days 10 (±4) and 1 (±1) before the index procedure.

Treatment:

Drug: Erythropoietin

Placebo

Placebo Comparator group

Description:

Dosage: Saline solution 0.9% Administered at days 10 (±4) and 1 (±1) before the index procedure.

Treatment:

Drug: Placebo