Effect of intravenous iron on cardiac repair

Phase 1

• Conditions: Heart failure with reduced left ventricular ejection fraction; MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001623-44-BE
• Lead Sponsor: Ziekenhuis Oost Limburg (ZOL), Genk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-04
• Last Update Posted: 27 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients with 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 < 45%).
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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: To assess left ventricular reverse remodeling also defined as left ventricular volumes and cardiac biomarkers;Primary end point(s): Change in left ventricular ejection fraction;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in left ventricular end-diastolic, end-systolic volume and cardiac biomarkers;Timepoint(s) of evaluation of this end point: 3 months