A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency /and Sub-Study
A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency /and Sub-Study
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
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.
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 six-minute walk test (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.
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
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:
Chicago, Illinois 60608, United States
Kalamazoo, Michigan 49008, United States
Camp Hill, Pennsylvania 17011, United States
Philadelphia, Pennsylvania 19104, United States
Rapid City, South Dakota 57701, United States
Richmond, Virginia 23249, United States
Spokane, Washington 99204, United States
Québec, Quebec G1V 4G5, Canada
Saint-Georges, Quebec G5Y 4T8, Canada
Trois-Rivières, Quebec G8Z 3R9, Canada
Budapest, 1085, Hungary
Newton, Wellington Region 6021, New Zealand
Nowy Dwór Mazowiecki, 05-100, Poland
Torun, 87-100, Poland
Kemerovo, 650002, Russia
Saint Petersburg, 192242, Russia
Saint Petersburg, 195257, Russia
Saratov, 410054, Russia
Ivano-Frankivsk, 76025, Ukraine
Kharkiv, 61058, Ukraine
Kryvyi Rih, 50031, Ukraine
Kyiv, 01103, Ukraine
Kyiv, 03049, Ukraine
Lviv, 79041, Ukraine
Vinnytsia, 21029, Ukraine
Zaporizhzhya, 69063, Ukraine
Zaporizhzhya, 69600, Ukraine