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

Primary Purpose

Anemia, Aortic Stenosis

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Erythropoietin

Placebo

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Severe aortic stenosis, Red blood cell transfusion, Erythropoietin

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients ≥60-year old
Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention
Anemia defined according to the World Health Organization (WHO) definition 69:
1. Men: Hemoglobin<130 g/L
2. Women: <120 g/L

Exclusion Criteria:

Contraindication for transcatheter aortic valve replacement.
Erythropoietin treatment within last 30 days before Aortic Valve Replacement
Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement
Ferritin>800 µg/L
Uncontrolled hypertension (Blood pressure>175/95 )
Platelet count>450,000/L
Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days)
Dialysis patients
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
Active cancer or very high risk of thromboembolic events
Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy
No written consent

Sites / Locations

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Erythropoietin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of red blood cell transfusion

Secondary Outcome Measures

Number of packets of red cells

Hemoglobin value

Analysis g/L

Hemoglobin value

Peak of troponin and creatinine kinase

Incidence of acute kidney injury

Acute kidney injury defined as >25% decrease of estimated glomerular filtration rate (eGFR)

Need of hemodialysis

Rate of new onset atrial fibrillation

Days of hospital stay

Days of intensive unit care stay

Mortality

Quality of life

Questionnaire, Visual scale

Cost-effectiveness analysis of Erythropoietin-therapy

Stroke rate

Full Information

NCT ID

NCT02390102

First Posted

January 21, 2013

Last Updated

July 16, 2018

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT02390102

Brief Title

Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

Acronym

EPICURE

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

June 2012 (Actual)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Aortic Stenosis

Keywords

Anemia, Severe aortic stenosis, Red blood cell transfusion, Erythropoietin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erythropoietin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Erythropoietin

Other Intervention Name(s)

Darboepoetin

Intervention Description

Combinaison drug of darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Saline solution

Intervention Description

Saline solution 0.9%

Primary Outcome Measure Information:

Title

Rate of red blood cell transfusion

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Number of packets of red cells

Time Frame

30 days

Title

Hemoglobin value

Description

Analysis g/L

Time Frame

One day before index procedure

Title

Hemoglobin value

Time Frame

For the duration of hospital stay, an expected average of 1 week

Title

Peak of troponin and creatinine kinase

Time Frame

For the duration of hospital stay, an expected average of 1 week

Title

Incidence of acute kidney injury

Description

Acute kidney injury defined as >25% decrease of estimated glomerular filtration rate (eGFR)

Time Frame

At 48 hours following procedure

Title

Need of hemodialysis

Time Frame

For the duration of hospital stay, an expected average of 1 week

Title

Rate of new onset atrial fibrillation

Time Frame

For the duration of hospital stay, an expected average of 1 week

Title

Days of hospital stay

Time Frame

For the duration of hospital stay, an expected average of 1 week

Title

Days of intensive unit care stay

Time Frame

For the duration of hospital stay, an expected average of 1 week

Title

Mortality

Time Frame

At 30-day, 1-year

Title

Quality of life

Description

Questionnaire, Visual scale

Time Frame

At 30-day, 6-month, 1-year

Title

Cost-effectiveness analysis of Erythropoietin-therapy

Time Frame

For the duration of hospital stay, an expected average of 1 week

Title

Stroke rate

Time Frame

At 30-day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients ≥60-year old Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention Anemia defined according to the World Health Organization (WHO) definition 69: Men: Hemoglobin<130 g/L Women: <120 g/L Exclusion Criteria: Contraindication for transcatheter aortic valve replacement. Erythropoietin treatment within last 30 days before Aortic Valve Replacement Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement Ferritin>800 µg/L Uncontrolled hypertension (Blood pressure>175/95 ) Platelet count>450,000/L Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days) Dialysis patients 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 Active cancer or very high risk of thromboembolic events Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy No written consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josep Rodes Cabau, MD

Organizational Affiliation

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

12. IPD Sharing Statement

Citations:

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Citation

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Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

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