search
Back to results

Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion (INFERRCT)

Primary Purpose

Myocardial Infarction, Acute

Status
Recruiting
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Ferinject
Sodium Chloride 0.9% Inj
Sponsored by
Wroclaw Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction, Acute focused on measuring Myocardial infarction, acute, iron deficiency, Infusion, ferric carboxymaltose

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years; Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks before randomisation; Presence of iron deficiency (ID) defined as transferrin saturation TSAT<20% and/or serum ferritin <100 ng/mL assessed up to 4 weeks before randomisation; Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present): LVEF ≤50%; NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; Diagnosis of diabetes mellitus (also de novo diagnosis); Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); Not complete revascularisation or/and no reperfusion (during an index AMI); History of AMI (despite an index AMI); eGFR <60 mL/min/1.73m2; Age ≥70 years. Written informed consent Exclusion Criteria: Subject temperature>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation; Severe, symptomatic valve disorder; Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation). Body weight <50 kg; Haemoglobin <8 g/dL or >15 g/dL; Serum ferritin >400 ng/mL; TSAT >40 %; Active gastroenteral bleeding; Known hypersensitivity to any of the administered preparations; Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation; Subject has known active malignancy of any organ system, i.e. clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia; Documented liver diseases; Participation in a device or drug trial within 3 months prior to randomisation or 5 half-lives, whichever period is longer, prior to the screening visit; 14) Pregnancy or lactation; 15) Any situation that may prevent the test from being performed in accordance with the protocol, or the consent of the investigator to be given in writing, including alcohol, drugs or any other substance overuse or addiction.

Sites / Locations

  • Zespół Opieki Zdrowotnej w KłodzkuRecruiting
  • Uniwersytecki Szpital kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuRecruiting
  • 4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZRecruiting
  • Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny RatunkowejRecruiting
  • Wielospecjalistyczny Szpital SP ZOZ w ZgorzelcuRecruiting
  • Vitamed BydgoszczRecruiting
  • Regionalny Szpital Specjalistyczny im. dr Wł. Biegańskiego w GrudziądzuRecruiting
  • Wojewódzki Szpital Zespolony im. L. Rydygiera w ToruniuRecruiting
  • 4Cardia Sp. z o.o.Recruiting
  • 1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie
  • Ośrodek Kardiologii Inwazyjnej IKARDIA Sp. z o.o.
  • Szpital Uniwersytecki imienia Karola Marcinkowskiego w Zielonej Górze Sp. z o. o.Recruiting
  • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Wojskowy Instytut Medyczny - Państwowy Instytut BadawczyRecruiting
  • Mazowiecki Szpital Bródnowski Sp. z o.o.Recruiting
  • Polsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-NaczynioweRecruiting
  • Szpital Specjalistyczny im. SS im. Henryka Klimontowicza w Gorlicach
  • Szpital Specjalistyczny im. J. Dietla w KrakowieRecruiting
  • Podhalański Szpital Specjalistyczny im. Jana Pawła II w Nowym TarguRecruiting
  • Medicome Sp. z o.o.Recruiting
  • Szpital Wojewódzki im. św. Łukasza SP ZOZ w TarnowieRecruiting
  • Centrum Kardiologii w Kluczborku Scanmed S.A.Recruiting
  • Polsko-Amerykańskie Kliniki Serca Centrum Sercowo-Naczyniowe w Kędzierzynie Koźlu
  • Uniwersytecki Szpital Kliniczny w OpoluRecruiting
  • Centrum Opieki Medycznej w JarosławiuRecruiting
  • Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii w Krośnie
  • Uniwersyteckim Centrum Kliniczne w Gdańsku
  • Polsko-Amerykańskie Kliniki Serca Centrum Kardiologiczno-Angiologiczne w Sztumie
  • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.Recruiting
  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie
  • Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii Med-Pro
  • Nzoz Salusmed
  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w ŁodziRecruiting
  • Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej
  • Polsko-Amerykańskie Kliniki Serca, X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w TychachRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

an i.v. 15-minute infusion of 20 mL Ferinject (containing 1000 mg of FCM) diluted in 50 mL of NaCl 0.9%

70 mL of i.v. NaCl 0.9% infusion

Outcomes

Primary Outcome Measures

Time to CV death assessed during the 12-month follow-up
Defined as: (with an implementation of a win ratio approach in a hierarchical descending order - pairwise comparison of each patient in the FCM group vs placebo group with the following hierarchy): Time to CV death assessed during the 12-month follow-up; Number of HFE assessed during the 12-month follow-up; Time to first HFE assessed during the 12-month follow-up; Change in QoL measured using EQ-5D change from baseline to an assessment at 8-month visit. *HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).
Number of HFE assessed during the 12-month follow-up
Number of HFE
Time to first HFE assessed during the 12-month follow-up
Time to first HFE
Change in Quality of life measured using EQ-5D change from baseline to an assessment at 8-month visit
Change in Quality of life

Secondary Outcome Measures

First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up up to 12 months (time-to-event model);
First unplanned HF hospitalisation or unplanned visit at emergency
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up up to 12 months (recurrent event model);
All unplanned HF hospitalisations and unplanned visit at emergency
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up up to 12 months (recurrent event model);
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up up to 12 months (recurrent event model);
All unplanned HF hospitalisations during the follow-up up to 12 months (recurrent event model);
All unplanned HF hospitalisations during the follow-up up to 12 months (recurrent event model);
CV death during the follow-up up to 12 months
CV death

Full Information

First Posted
January 16, 2023
Last Updated
September 19, 2023
Sponsor
Wroclaw Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05759078
Brief Title
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
Acronym
INFERRCT
Official Title
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion SUBTITLE Prevention of Cardiovascular Death, Heart Failure Events and Deterioration in Quality of Life With INtravenous FERRic Carboxymaltose in Iron Deficient Patients With Recent Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
June 14, 2026 (Anticipated)
Study Completion Date
June 14, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wroclaw Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Non-commercial, multicentre, randomised, double-blind, parallel group, placebo-controlled clinical trial. Eligible patients were randomly assigned (1:1) using a secure, central, interactive, web-based response system, to intervention FCM or placebo arm. Time of observation 12 months [12 main study + 3 years follow up in substudy B]. Primary Study Objective: Primary: Evaluation of the effect of i.v. FCM treatment compared with placebo on the risk of cardiovascular (CV) death, the risk of heart failure events (HFE*) (number of events and time to first event) during the 12-month follow-up and the change in quality of life (QoL) assessed using EQ-5D during the 8-month follow-up in patients with recent AMI and ID (with an implementation of a win ratio approach in a hierarchical descending order). *HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute
Keywords
Myocardial infarction, acute, iron deficiency, Infusion, ferric carboxymaltose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Non-commercial, multicentre, randomised, double-blind, parallel group, placebo-controlled clinical trial. Eligible patients were randomly assigned (1:1) using a secure, central, interactive, web-based response system, to intervention FCM or placebo arm. Time of observation 12 months [12 main study + 3 years follow up in substudy B].
Masking
ParticipantCare ProviderInvestigator
Masking Description
A drip will be prepared by unblinded personnel using masked bottle, light brown lines for infusion, and administered immediately after preparation using a special curtain (screen).
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
an i.v. 15-minute infusion of 20 mL Ferinject (containing 1000 mg of FCM) diluted in 50 mL of NaCl 0.9%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
70 mL of i.v. NaCl 0.9% infusion
Intervention Type
Drug
Intervention Name(s)
Ferinject
Intervention Description
The first dose of FCM will be administered during the first visit on the day of randomisation (V1). Then, the participants will be reassessed at 4 and 8 months (visits V2, V3) for: haemoglobin, serum ferritin and TSAT. They will receive an additional dose of 1000 mg of FCM during these visits if ferritin <100 ng/mL or/and TSAT <20% (ferritin cannot exceed 400 ng/dL, TSAT cannot exceed 40%, haemoglobin cannot exceed 15 g/dL). If these criteria are not fulfilled, a patient in the active study arm will receive i.v. NaCl 0.9% during the particular visit.
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9% Inj
Intervention Description
The first dose of placebo will be administered during the first visit on the day of randomisation (V1). During visits V2 i V3 (at 4 and 8 months) they will receive next dose of placebo.
Primary Outcome Measure Information:
Title
Time to CV death assessed during the 12-month follow-up
Description
Defined as: (with an implementation of a win ratio approach in a hierarchical descending order - pairwise comparison of each patient in the FCM group vs placebo group with the following hierarchy): Time to CV death assessed during the 12-month follow-up; Number of HFE assessed during the 12-month follow-up; Time to first HFE assessed during the 12-month follow-up; Change in QoL measured using EQ-5D change from baseline to an assessment at 8-month visit. *HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).
Time Frame
12 months
Title
Number of HFE assessed during the 12-month follow-up
Description
Number of HFE
Time Frame
12 months
Title
Time to first HFE assessed during the 12-month follow-up
Description
Time to first HFE
Time Frame
12 months
Title
Change in Quality of life measured using EQ-5D change from baseline to an assessment at 8-month visit
Description
Change in Quality of life
Time Frame
8 months
Secondary Outcome Measure Information:
Title
First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up up to 12 months (time-to-event model);
Description
First unplanned HF hospitalisation or unplanned visit at emergency
Time Frame
12 months
Title
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up up to 12 months (recurrent event model);
Description
All unplanned HF hospitalisations and unplanned visit at emergency
Time Frame
12 months
Title
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up up to 12 months (recurrent event model);
Description
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up up to 12 months (recurrent event model);
Time Frame
12 months
Title
All unplanned HF hospitalisations during the follow-up up to 12 months (recurrent event model);
Description
All unplanned HF hospitalisations during the follow-up up to 12 months (recurrent event model);
Time Frame
12 months
Title
CV death during the follow-up up to 12 months
Description
CV death
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
First unplanned CV hospitalisation or CV death during the follow-up up to 12 months (time-to-event model);
Description
First unplanned CV hospitalisation or CV death during the follow-up
Time Frame
12 months
Title
All unplanned CV hospitalisations and CV death during the follow-up up to 12 months (recurrent event model);
Description
All unplanned CV hospitalisations and CV death during the follow-up
Time Frame
12 months
Title
All unplanned CV hospitalisations during the follow-up up to 12 months (recurrent event model);
Description
All unplanned CV hospitalisations during the follow-up up to 12 months (recurrent event model);
Time Frame
12 months
Title
Non-CV death during the follow-up up to 12 months
Description
Non-CV death during the follow-up up to 12 months
Time Frame
12 months
Title
All-cause death during the follow-up up to 12 months
Description
All-cause death during the follow-up up to 12 months
Time Frame
12 months
Title
Ambulatory significant intensification of diuretic therapy during the follow-up up to 12 months
Description
Ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms) during the follow-up up to 12 months
Time Frame
12 months
Title
Change in QoL scores (assessed using EQ-5D) from baseline to 4, 8 and 12 months since randomisation;
Description
Change in QoL scores (assessed using EQ-5D) from baseline to 4, 8 and 12 months since randomisation;
Time Frame
12 months
Title
Change in PGA from baseline to 4, 8 and 12 months since randomisation
Description
Change in PGA from baseline to 4, 8 and 12 months since randomisation
Time Frame
12 months
Title
Change in NT-proBNP from baseline 4, 8 and 12 months since randomisation;
Description
Change in NT-proBNP from baseline 4, 8 and 12 months since randomisation;
Time Frame
12 months
Title
Change in other biomarkers from baseline to 4, 8 and 12 months since randomisation (substudy A)
Description
Under redesigning process - details will be published at the later stage
Time Frame
12 months
Title
Cost-effectiveness measures during the follow-up up to 12 months
Description
Any unplanned CV hospitalisation (recurrent event model and time to event models) Ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms) during the follow-up up to 12 months; Change in QoL scores (assessed using EQ-5D) from baseline to 4, 8 and 12 months since randomisation; Change in PGA from baseline to 4, 8 and 12 months since randomisation
Time Frame
12 months
Title
Secondary and other aforementioned other outcomes during the followup up to 3 years (Substudy B - extension study).
Description
Substudy B - phone calls every 4 months up to 3 years of follow up (AE/SAE reports and enpoints).
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years; Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks before randomisation; Presence of iron deficiency (ID) defined as transferrin saturation TSAT<20% and/or serum ferritin <100 ng/mL assessed up to 4 weeks before randomisation; Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present): LVEF ≤50%; NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; Diagnosis of diabetes mellitus (also de novo diagnosis); Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); Not complete revascularisation or/and no reperfusion (during an index AMI); History of AMI (despite an index AMI); eGFR <60 mL/min/1.73m2; Age ≥70 years. Written informed consent Exclusion Criteria: Subject temperature>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation; Severe, symptomatic valve disorder; Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation). Body weight <50 kg; Haemoglobin <8 g/dL or >15 g/dL; Serum ferritin >400 ng/mL; TSAT >40 %; Active gastroenteral bleeding; Known hypersensitivity to any of the administered preparations; Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation; Subject has known active malignancy of any organ system, i.e. clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia; Documented liver diseases; Participation in a device or drug trial within 3 months prior to randomisation or 5 half-lives, whichever period is longer, prior to the screening visit; 14) Pregnancy or lactation; 15) Any situation that may prevent the test from being performed in accordance with the protocol, or the consent of the investigator to be given in writing, including alcohol, drugs or any other substance overuse or addiction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Duda-Sikuła
Phone
717840696
Ext
0048
Email
marta.duda-sikula@umw.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Raińczuk
Phone
717840697
Email
julia.rainczuk@umw.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Ponikowski
Organizational Affiliation
Wroclaw Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zespół Opieki Zdrowotnej w Kłodzku
City
Kłodzko
State/Province
Dolnośląskie
ZIP/Postal Code
57-300
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
74 865 12 00
Facility Name
Uniwersytecki Szpital kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
71 736 42 76
Facility Name
4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
50-981
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
26 166 05 55
Facility Name
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny Ratunkowej
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
54-049
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
71 306 44 19
Facility Name
Wielospecjalistyczny Szpital SP ZOZ w Zgorzelcu
City
Zgorzelec
State/Province
Dolnośląskie
ZIP/Postal Code
59-900
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
75 772 29 00
Facility Name
Vitamed Bydgoszcz
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-079
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
52 347 88 15
Facility Name
Regionalny Szpital Specjalistyczny im. dr Wł. Biegańskiego w Grudziądzu
City
Grudziądz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
86-300
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
56 641 44 44
Facility Name
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
City
Toruń
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
56 679 31 00
Facility Name
4Cardia Sp. z o.o.
City
Kraśnik
State/Province
Lubelskie
ZIP/Postal Code
23-204
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
81 458 77 88
Facility Name
1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-049
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Ośrodek Kardiologii Inwazyjnej IKARDIA Sp. z o.o.
City
Nałęczów
State/Province
Lubelskie
ZIP/Postal Code
24-140
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Uniwersytecki imienia Karola Marcinkowskiego w Zielonej Górze Sp. z o. o.
City
Zielona Góra
State/Province
Lubuskie
ZIP/Postal Code
65-046
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
68 329 62 00
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-349
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
26 181 76 66
Facility Name
Mazowiecki Szpital Bródnowski Sp. z o.o.
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-242
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
22 326 52 26
Facility Name
Polsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-Naczyniowe
City
Chrzanów
State/Province
Małopolskie
ZIP/Postal Code
32-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
32 758 69 00
Facility Name
Szpital Specjalistyczny im. SS im. Henryka Klimontowicza w Gorlicach
City
Gorlice
State/Province
Małopolskie
ZIP/Postal Code
38-300
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Specjalistyczny im. J. Dietla w Krakowie
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
31-121
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
12 68 76 200
Facility Name
Podhalański Szpital Specjalistyczny im. Jana Pawła II w Nowym Targu
City
Nowy Targ
State/Province
Małopolskie
ZIP/Postal Code
34-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
18 263 30 00
Facility Name
Medicome Sp. z o.o.
City
Oświęcim
State/Province
Małopolskie
ZIP/Postal Code
32-600
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48 505 121 703
Facility Name
Szpital Wojewódzki im. św. Łukasza SP ZOZ w Tarnowie
City
Tarnów
State/Province
Małopolskie
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
14 631 50 00
Facility Name
Centrum Kardiologii w Kluczborku Scanmed S.A.
City
Kluczbork
State/Province
Opolskie
ZIP/Postal Code
46-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
77 410 82 18
Facility Name
Polsko-Amerykańskie Kliniki Serca Centrum Sercowo-Naczyniowe w Kędzierzynie Koźlu
City
Kędzierzyn-Koźle
State/Province
Opolskie
ZIP/Postal Code
47-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
77 472 25 65
Facility Name
Uniwersytecki Szpital Kliniczny w Opolu
City
Opole
State/Province
Opolskie
ZIP/Postal Code
45-401
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
77 452 07 45
Facility Name
Centrum Opieki Medycznej w Jarosławiu
City
Jarosław
State/Province
Podkarpackie
ZIP/Postal Code
37-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
16 621 54 21
Facility Name
Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii w Krośnie
City
Krosno
State/Province
Podkarpackie
ZIP/Postal Code
38-400
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersyteckim Centrum Kliniczne w Gdańsku
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
58 349 20 00
Facility Name
Polsko-Amerykańskie Kliniki Serca Centrum Kardiologiczno-Angiologiczne w Sztumie
City
Sztum
State/Province
Pomorskie
ZIP/Postal Code
82-400
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
55 625 92 20
Facility Name
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
City
Słupsk
State/Province
Pomorskie
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
59 846 07 00
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii Med-Pro
City
Zgierz
State/Province
Łódzkie
ZIP/Postal Code
95-100
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
42 231 47 00
Facility Name
Nzoz Salusmed
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
91-002
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
42 201 42 40
Facility Name
Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej
City
Bielsko-Biala
State/Province
Śląskie
ZIP/Postal Code
43-316
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
33 828 93 70
Facility Name
Polsko-Amerykańskie Kliniki Serca, X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach
City
Tychy
State/Province
Śląskie
ZIP/Postal Code
43-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
32 758 67 00

12. IPD Sharing Statement

Links:
URL
https://inferrct.umw.edu.pl/
Description
INFERRCT study website

Learn more about this trial

Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion

We'll reach out to this number within 24 hrs