Heart Failure with Iron Deficiency MedDRA version: 20.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851 MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Injectafer®
Product Name: Injectafer®
Pharmaceutical Form: Injection
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
American Regent, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (=18 years of age) able to provide signed, written informed consent. 2. Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 2 weeks prior to randomization. 3. Able and willing to perform a 6MWT at the time of randomization. 4. Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical intervention including coronary artery bypass graft (CABG),valvular repair/replacement, or cardiac resynchronization therapy (CRT) device implantation. a. Left ventricular ejection fraction =40% obtained during the screening visit OR either of the following i. Historical value of ejection fraction =40% within 24 months of screening visit ii. Historical value of ejection fraction =30% within 36 months of screening visit 5. Hemoglobin >9.0 g/dL and 600 pg/mL (or BNP >200 pg/mL) b. For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL 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 1508 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1508
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity reaction to any component of FCM. 2. History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion. 3. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment. 4. Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention. 5. Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest). 6. Current or planned mechanical circulatory support or heart transplantation. 7. Hemodialysis or peritoneal dialysis (current or planned within the next 6 months). 8. Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range). 9. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia. 10. Active gastrointestinal bleeding. 11. Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication. 12. Inability to return for follow up visits within the necessary windows 13. Concurrently in a study with investigational product. 14. Current COVID-19 infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency.;Secondary Objective: To evaluate the effect of IV FCM, relative to placebo, on the functional capacity of patients in heart failure with reduced ejection fraction and with iron deficiency.;Primary end point(s): Hierarchical composite of 1) death, 2) hospitalization for heart failure (defined in section 10.2), or 3) change in 6MWT. (Death and hospitalizations for heart failure will be evaluated at one year, Change in 6MWT will be evaluated at 6 months) and tested using the nonparametric Wilcoxon-type test.;Timepoint(s) of evaluation of this end point: as above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to first event of the composite of cardiovascular death or heart failure hospitalization. The composite endpoint will be composed of adjudicated occurrence of one of the following: a. Cardiovascular Death i. Death due to Heart Failure ii. Death due to Acute Myocardial Infarction iii. Sudden Cardiac Death iv. Death due to Stroke v. Death due to other Cardiovascular Causes b. Hospitalization for Worsening Heart Failure 2. Mean change in 6MWT from baseline to 12 months 3. Time to first event of the composite of cardiovascular death or intervention for worsening heart failure (hospitalization or urgent heart failure visits) 4. Time to first event of the composite of cardiovascular death and cardiovascular hospitalizations 5. Time to cardiovascular death Additional events to be adjudicated for analysis of the secondary endpoints include: a) Non-cardiovascular death b) Hospitalization for myocardial infarction c) Hospitalization for stroke d) Other cardiovascular hospitalizations e) Urgent heart failure visits;Timepoint(s) of evaluation of this end point: as above | — |
Countries
Australia, Canada, Georgia, Hungary, Latvia, Lithuania, New Zealand, Poland, Ukraine, United States
Contacts
Public ContactClinical Trial Information
American Regent Inc
Outcome results
None listed