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

NCT ID: NCT03380520

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2021-08-04

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ferric carboxymaltose

Ferric carboxymaltose according to SmPC

Group Type: EXPERIMENTAL

Ferric Carboxymaltose

Intervention Type: DRUG

Ferric carboxymaltose will be administered according to product specification dosing

Placebo

Normal saline (0.9%)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV nacl 0.9%

Interventions

Ferric Carboxymaltose

Ferric carboxymaltose will be administered according to product specification dosing

Intervention Type: DRUG

Placebo

IV nacl 0.9%

Intervention Type: DRUG

Other Intervention Names

injectafer

Eligibility Criteria

Inclusion Criteria

1. 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%).

2. Age ≥18 years

3. Obtained informed consent

4. Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)

Exclusion Criteria

1. Hemochromatosis, iron overload, defined as TSAT > 45%

2. Hemoglobin > 15 g/dl at inclusion

3. Known hypersensitivity to injectafer®.

4. Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.

5. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.

6. Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).

7. 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.

8. 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.

9. Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months.

10. 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.

11. Inability to fully comprehend and/or perform study procedures in the investigator's opinion.

12. Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).

13. Pregnancy or lactation.

14. Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.

15. Planned cardiac hospitalization during study follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Wilfried Mullens, MD PhD

Md PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pieter Martens

Genk, Limburg, Belgium

Countries

Belgium

References

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.

Reference Type: RESULT

PMID: 34185066 (View on PubMed)

Other Identifiers

IRON-CRT

Identifier Type: -

Identifier Source: org_study_id