Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Heart Failure, Iron-deficiency

In brief

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

Key facts

Study ID

NCT03037931

Run by

American Regent, Inc.

People needed

3065

Starts

2017-03-15

Expected to finish

2023-02-02

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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) .

You may not qualify if…

• 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 Coronavirus Disease-19 (COVID-19) Infection into the study.

Where it is running

• Advanced Cardiovascular, LLC — Auburn, Alabama, United States
• IMC/Diagnostic & Medical Clinic — Mobile, Alabama, United States
• University of South Alabama — Mobile, Alabama, United States
• Alaska Heart & Vascular Institute — Anchorage, Alaska, United States
• Verde Valley Medical Center — Cottonwood, Arizona, United States
• Clinical Research Institute of Arizona, LLC — Surprise, Arizona, United States
• Carondelet Heart and Vascular Institute - Cardiology East — Tucson, Arizona, United States
• Sparks Regional Medical Center — Fort Smith, Arkansas, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Westside Medical Associates of Los Angeles — Beverly Hills, California, United States
• Harbor-UCLA Medical Center — Carson, California, United States
• Valley Clinical Trials, Inc. — Covina, California, United States
• TriWest Research Associates, LLC — El Cajon, California, United States
• California Heart Specialists — Huntington Beach, California, United States
• First Valley Medical Group — Lancaster, California, United States
• Healthcare Partners Affiliation Medical Group — Long Beach, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• St. Joseph Heritage-Healthcare — Mission Viejo, California, United States
• Radin Cardiovascular Medical Group, Inc. — Newport Beach, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Pasadena Clinical Research — Pasadena, California, United States
• Eugene Soroka, MD Inc. — Port Hueneme, California, United States
• VA San Diego Health Care System — San Diego, California, United States
• Advanced Cardiovascular LLC — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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