Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency

  • STATUS
    Recruiting
  • End date
    Jun 20, 2023
  • participants needed
    3014
  • sponsor
    American Regent, Inc.
Updated on 20 August 2021
iron
ejection fraction
heart failure
bypass graft
nt-probnp
nesiritide
b-type natriuretic peptide
natriuretic peptide
cardiac resynchronization therapy

Summary

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

Description

This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) distance for patients in heart failure with iron deficiency.

After an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment.

Study drug administration will occur on Day 0 and Day 7 (2) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. In a subset of sites, a sub-study will be conducted to characterize serum phosphate levels over time in participants with heart failure and iron deficiency after dosing with FCM. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.

Details
Condition Heart failure, Heart disease, Iron deficiency anemia, Iron Deficiency, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease, anemia, iron deficiency
Treatment Placebo, placebos, Ferric carboxymaltose
Clinical Study IdentifierNCT03037931
SponsorAmerican Regent, Inc.
Last Modified on20 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult (18 years of age) able to provide signed, written informed consent
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
Able and willing to perform a 6MWT at the time of randomization
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
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
Hemoglobin >9.0 g/dL and < 13.5 g/dL (females) or <15.0 g/dL (males) within 28 days of randomization
Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.Patients with screening ferritin <15 ng/mL must have documentation of an appropriate evaluation, as determined by the Principle Investigator, within 3 months of screening and prior to randomization
Either documented hospitalization for heart failure within 12 months of enrollment or elavated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization. a. For patients in normal sinus rhythm: N-terminal-pro-brain natriuretic peptide (NT- proBNP) > 600 pg/mL (or BNP >200 pg/mL) . b . For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL)

Exclusion Criteria

Known hypersensitivity reaction to any component of FCM
History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion
Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment
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
Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest)
Current or planned mechanical circulatory support or heart transplantation
Hemodialysis or peritoneal dialysis (current or planned within the next 6 months)
Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range)
Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia
Active gastrointestinal bleeding
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
Inability to return for follow up visits within the necessary windows
Concurrently in a study with investigational product
No participants with Current COVID-19 Infection into the study
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