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

Heart Failure Clinical Trial

— IRON-CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380520
• Other study ID #: IRON-CRT
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: August 4, 2021

Study information

• Verified date: August 2021
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 4, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Ferric Carboxymaltose
Ferric carboxymaltose will be administered according to product specification dosing
• Placebo
IV nacl 0.9%

Locations

Country	Name	City	State
Belgium	Pieter Martens	Genk	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predefined right ventricular (RV) analysis	Assessment of effect of FCM on RV-function at rest and during incremental pacing. Assessment of RV-to-pulmonary artery coupling	3 months
Primary	Change in left ventricular ejection fraction from baseline	delta_LVEF measured by 3D-echocardiography	3 months
Secondary	Change in left ventricular end systolic volume from baseline	delta_LVESV measured by 3D-echocardiography	3 months
Secondary	Change in left ventricular end diastolic volume from baseline	delta_LVEDV measured by 3D-echocardiography	3 months
Secondary	Force frequency relationship	measured by 2D-echocardiography	3 months
Secondary	Heart failure hospitalization and all-cause mortality	measured by telephone contact	Up to six months
Secondary	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).	During intravenous study drug administration and 1-hour in hospital follow-up