Back to resultsAn Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function (OPERA-MI)
Primary Purpose
Myocardial Infarction, Iron-deficiency
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
ferric carboxymaltose
ferrous sulphate
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Iron-deficiency, WMSI, ferric carboxymaltose, left ventricular systolic function
Eligibility Criteria
Inclusion Criteria:
- Adult (≥18 years of age) able to provide informed consent. Hospitalized myocardial infarction patients (that diagnosed according to Fourth Universal Definition of myocardial infarction and myocardial injury, ESC 2018) with hypokinesia or akinesia in at least two connected left ventricular segments according to echocardiography results obtained within the first 24 hours after myocardial infarction occurs.
- Hemoglobin >9.0 g/dL and <15,0 g/dl and serum iron <12 µmol/l on screening visit.
- Serum ferritin <100 μg/L, or 100-299 μg/L when transferrin saturation <20%.
Exclusion Criteria:
- Known hypersensitivity reaction to any component of ferric carboxymaltose.
- History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, i.v. iron therapy, or blood transfusion.
- Heart failure Killip class II-IV on screening visit.
- Current or planned mechanical circulatory support or heart transplantation.
- Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
- Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).
- Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
- Active gastrointestinal bleeding.
- Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
- Inability to return for follow up visits within the necessary period of time.
Sites / Locations
- Kazan State Medical UniversetyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
FCM group
Ferrous sulphate group
Group with normal iron status
Arm Description
The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels.
100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month.
Patiants with normal iron status
Outcomes
Primary Outcome Measures
decrease in the wall motion score index
WMSI reflects the left ventricular systolic function and calculated by dividing the sum of the aforementioned segmental values by the number of myocardial segments (16). There are no spetial units of measure for it.
Secondary Outcome Measures
composite outcome
composite of cardio-vascular (CV) mortality, non-fatal stroke, non-fatal MI, recurrent HF hospitalizations.
Full Information
NCT ID
NCT05309499
First Posted
March 24, 2022
Last Updated
April 3, 2022
Sponsor
Kazan State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05309499
Brief Title
An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function
Acronym
OPERA-MI
Official Title
An Open, Prospective, Randomized Study on the Efficacy of Iron Therapy Using Intravenous (IV) Iron Supplements Relative to Oral Iron Intake for Increasing Left Ventricular Systolic Function in Patients With Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2021 (Actual)
Primary Completion Date
December 5, 2023 (Anticipated)
Study Completion Date
December 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kazan State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The OPERA-MI trial evaluates the effect of i.v. ferric carboxymaltose compared to the effect of oral iron, on left ventricular systolic function.
Detailed Description
For this study an open-label prospective randomized approach is used. During the study 360 patients with or without ID, who hospitalized for myocardial infarction were signed up. Patients were randomised (1:1) to either intravenous. FCM or oral ferrous sulphate and received the treatment during hospitalisation. Patients are closely followed for 1 year. The primary outcome is a decrease in the Wall Motion Score Index value in FCM group compered to ferrous sulphate group. The main secondary outcome includes the composite of cardio-vascular mortality, non-fatal stroke, non-fatal MI, recurrent heart failure hospitalizations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Iron-deficiency
Keywords
Myocardial Infarction, Iron-deficiency, WMSI, ferric carboxymaltose, left ventricular systolic function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FCM group
Arm Type
Active Comparator
Arm Description
The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels.
Arm Title
Ferrous sulphate group
Arm Type
Active Comparator
Arm Description
100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month.
Arm Title
Group with normal iron status
Arm Type
No Intervention
Arm Description
Patiants with normal iron status
Intervention Type
Drug
Intervention Name(s)
ferric carboxymaltose
Intervention Description
ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group
Intervention Type
Drug
Intervention Name(s)
ferrous sulphate
Intervention Description
ferrous sulphate is oral iron, 121patiants will be randomised to this group
Primary Outcome Measure Information:
Title
decrease in the wall motion score index
Description
WMSI reflects the left ventricular systolic function and calculated by dividing the sum of the aforementioned segmental values by the number of myocardial segments (16). There are no spetial units of measure for it.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
composite outcome
Description
composite of cardio-vascular (CV) mortality, non-fatal stroke, non-fatal MI, recurrent HF hospitalizations.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (≥18 years of age) able to provide informed consent. Hospitalized myocardial infarction patients (that diagnosed according to Fourth Universal Definition of myocardial infarction and myocardial injury, ESC 2018) with hypokinesia or akinesia in at least two connected left ventricular segments according to echocardiography results obtained within the first 24 hours after myocardial infarction occurs.
Hemoglobin >9.0 g/dL and <15,0 g/dl and serum iron <12 µmol/l on screening visit.
Serum ferritin <100 μg/L, or 100-299 μg/L when transferrin saturation <20%.
Exclusion Criteria:
Known hypersensitivity reaction to any component of ferric carboxymaltose.
History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, i.v. iron therapy, or blood transfusion.
Heart failure Killip class II-IV on screening visit.
Current or planned mechanical circulatory support or heart transplantation.
Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).
Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
Active gastrointestinal bleeding.
Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
Inability to return for follow up visits within the necessary period of time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilyara Khastieva, MD
Phone
+79050204407
Email
dilyara_khastieva@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Niaz Khasanov, Professor
Phone
+79872906021
Email
ybzp@mail.ru
Facility Information:
Facility Name
Kazan State Medical Universety
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420012
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niaz Khasanov, professor
Phone
+79872906021
Email
ybzp@mail.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function
We'll reach out to this number within 24 hrs