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Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy (IRON-CRT)

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Ferric Carboxymaltose

Placebo

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin < 100 μg/l, irrespective of TSAT or ferritine between 100 - 300 μg/l with TSAT < 20%) and presence of incomplete reverse remodeling (LVEF < 40%).
Age ≥18 years
Obtained informed consent
Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)

Exclusion Criteria:

Hemochromatosis, iron overload, defined as TSAT > 45%
Hemoglobin > 15 g/dl at inclusion
Known hypersensitivity to injectafer®.
Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.
Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
History of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months.
Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).
Pregnancy or lactation.
Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
Planned cardiac hospitalization during study follow-up

Sites / Locations

Pieter Martens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ferric carboxymaltose

Placebo

Arm Description

Ferric carboxymaltose according to SmPC

Normal saline (0.9%)

Outcomes

Primary Outcome Measures

Change in left ventricular ejection fraction from baseline

delta_LVEF measured by 3D-echocardiography

Secondary Outcome Measures

Change in left ventricular end systolic volume from baseline

delta_LVESV measured by 3D-echocardiography

Change in left ventricular end diastolic volume from baseline

delta_LVEDV measured by 3D-echocardiography

Force frequency relationship

measured by 2D-echocardiography

Heart failure hospitalization and all-cause mortality

measured by telephone contact

Incidence of Treatment-associated Serious and non-serious adverse events.

Serious and non-serious adverse events (AE) will be registered, which include:start date AE, duration AE, end-date AE, treatment group, continuation of AE after dose interruption, causality with study medication, presence of risk factors for AE and response to AE (sequela or recovery).

Full Information

NCT ID

NCT03380520

First Posted

November 2, 2017

Last Updated

August 4, 2021

Sponsor

Hasselt University

Collaborators

Ziekenhuis Oost-Limburg

1. Study Identification

Unique Protocol Identification Number

NCT03380520

Brief Title

Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy

Acronym

IRON-CRT

Official Title

Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

August 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hasselt University

Collaborators

Ziekenhuis Oost-Limburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo

6. Conditions and Keywords

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

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ferric carboxymaltose

Arm Type

Experimental

Arm Description

Ferric carboxymaltose according to SmPC

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal saline (0.9%)

Intervention Type

Drug

Intervention Name(s)

Ferric Carboxymaltose

Other Intervention Name(s)

injectafer

Intervention Description

Ferric carboxymaltose will be administered according to product specification dosing

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

IV nacl 0.9%

Primary Outcome Measure Information:

Title

Change in left ventricular ejection fraction from baseline

Description

delta_LVEF measured by 3D-echocardiography

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change in left ventricular end systolic volume from baseline

Description

delta_LVESV measured by 3D-echocardiography

Time Frame

3 months

Title

Change in left ventricular end diastolic volume from baseline

Description

delta_LVEDV measured by 3D-echocardiography

Time Frame

3 months

Title

Force frequency relationship

Description

measured by 2D-echocardiography

Time Frame

3 months

Title

Heart failure hospitalization and all-cause mortality

Description

measured by telephone contact

Time Frame

Up to six months

Title

Incidence of Treatment-associated Serious and non-serious adverse events.

Description

Time Frame

During intravenous study drug administration and 1-hour in hospital follow-up

Other Pre-specified Outcome Measures:

Title

Predefined right ventricular (RV) analysis

Description

Assessment of effect of FCM on RV-function at rest and during incremental pacing. Assessment of RV-to-pulmonary artery coupling

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin < 100 μg/l, irrespective of TSAT or ferritine between 100 - 300 μg/l with TSAT < 20%) and presence of incomplete reverse remodeling (LVEF < 40%). Age ≥18 years Obtained informed consent Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics) Exclusion Criteria: Hemochromatosis, iron overload, defined as TSAT > 45% Hemoglobin > 15 g/dl at inclusion Known hypersensitivity to injectafer®. Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range. Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months). History of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months. Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias. Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months. Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months. Inability to fully comprehend and/or perform study procedures in the investigator's opinion. Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy). Pregnancy or lactation. Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study. Planned cardiac hospitalization during study follow-up

Facility Information:

Facility Name

Pieter Martens

City

Genk

State/Province

Limburg

ZIP/Postal Code

3500

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Yes, full patient level data

Citations:

PubMed Identifier

34185066

Citation

Martens P, Dupont M, Dauw J, Nijst P, Herbots L, Dendale P, Vandervoort P, Bruckers L, Tang WHW, Mullens W. The effect of intravenous ferric carboxymaltose on cardiac reverse remodelling following cardiac resynchronization therapy-the IRON-CRT trial. Eur Heart J. 2021 Dec 21;42(48):4905-4914. doi: 10.1093/eurheartj/ehab411.

Results Reference

result

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Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy

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