Clinical trial NCT02390102: Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement
Official title: Combined ErythroPoietin and Iron Therapy for AnemiC Patients With Severe Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve REplacement- The EPICURE Trial A Prospective Double Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Aortic Stenosis
Keywords: Anemia
Severe aortic stenosis
Red blood cell transfusion
Erythropoietin
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 117
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of red blood cell transfusion
timeFrame: 30 days
Secondary outcomes:
measure: Number of packets of red cells
timeFrame: 30 days
measure: Hemoglobin value
timeFrame: One day before index procedure
measure: Hemoglobin value
timeFrame: For the duration of hospital stay, an expected average of 1 week
measure: Peak of troponin and creatinine kinase
timeFrame: For the duration of hospital stay, an expected average of 1 week
measure: Incidence of acute kidney injury
timeFrame: At 48 hours following procedure
measure: Need of hemodialysis
timeFrame: For the duration of hospital stay, an expected average of 1 week
measure: Rate of new onset atrial fibrillation
timeFrame: For the duration of hospital stay, an expected average of 1 week
measure: Days of hospital stay
timeFrame: For the duration of hospital stay, an expected average of 1 week
measure: Days of intensive unit care stay
timeFrame: For the duration of hospital stay, an expected average of 1 week
measure: Mortality
timeFrame: At 30-day, 1-year
measure: Quality of life
timeFrame: At 30-day, 6-month, 1-year
measure: Cost-effectiveness analysis of Erythropoietin-therapy
timeFrame: For the duration of hospital stay, an expected average of 1 week
measure: Stroke rate
timeFrame: At 30-day
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study officials:
affiliation: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
name: Josep Rodes Cabau, MD
role: PRINCIPAL_INVESTIGATOR
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