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

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

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quebec, Canada, G1V 4G5
        • Institut Universitaire de cardiologie et de pneumologie de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erythropoietin
Dose: darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose Administered at days 10 (±4) and 1 (±1) before the index procedure.
Combinaison drug of darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose
Other Names:
  • Darboepoetin
Placebo Comparator: Placebo
Dosage: Saline solution 0.9% Administered at days 10 (±4) and 1 (±1) before the index procedure.
Saline solution 0.9%
Other Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of red blood cell transfusion
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of packets of red cells
Time Frame: 30 days
30 days
Hemoglobin value
Time Frame: One day before index procedure
Analysis g/L
One day before index procedure
Hemoglobin value
Time Frame: For the duration of hospital stay, an expected average of 1 week
For the duration of hospital stay, an expected average of 1 week
Peak of troponin and creatinine kinase
Time Frame: For the duration of hospital stay, an expected average of 1 week
For the duration of hospital stay, an expected average of 1 week
Incidence of acute kidney injury
Time Frame: At 48 hours following procedure
Acute kidney injury defined as >25% decrease of estimated glomerular filtration rate (eGFR)
At 48 hours following procedure
Need of hemodialysis
Time Frame: For the duration of hospital stay, an expected average of 1 week
For the duration of hospital stay, an expected average of 1 week
Rate of new onset atrial fibrillation
Time Frame: For the duration of hospital stay, an expected average of 1 week
For the duration of hospital stay, an expected average of 1 week
Days of hospital stay
Time Frame: For the duration of hospital stay, an expected average of 1 week
For the duration of hospital stay, an expected average of 1 week
Days of intensive unit care stay
Time Frame: For the duration of hospital stay, an expected average of 1 week
For the duration of hospital stay, an expected average of 1 week
Mortality
Time Frame: At 30-day, 1-year
At 30-day, 1-year
Quality of life
Time Frame: At 30-day, 6-month, 1-year
Questionnaire, Visual scale
At 30-day, 6-month, 1-year
Cost-effectiveness analysis of Erythropoietin-therapy
Time Frame: For the duration of hospital stay, an expected average of 1 week
For the duration of hospital stay, an expected average of 1 week
Stroke rate
Time Frame: At 30-day
At 30-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Josep Rodes Cabau, MD, Institut Universitaire de cardiologie et de pneumologie de Quebec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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