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Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency (HEART-FID)

This study is currently recruiting participants.
Verified December 2017 by Luitpold Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT03037931
First Posted: January 31, 2017
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
  Purpose
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 iron deficiency and with a reduced ejection fraction.

Condition Intervention Phase
Heart Failure Iron-deficiency Drug: Ferric carboxymaltose Drug: Placebos Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of Death [ Time Frame: 1 year ]
  • Incidence of hospitalization for heart failure [ Time Frame: 1 year ]
  • Change in 6MWT distance [ Time Frame: 6 months ]

Estimated Enrollment: 3014
Actual Study Start Date: March 15, 2017
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ferric Carboxymaltose
Ferric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by iron indices
Drug: Ferric carboxymaltose
Intravenous Iron
Other Name: Injectafer, Ferinject
Placebo Comparator: Placebos
Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.
Drug: Placebos
Normal Saline Solution
Other Name: Saline solution

Detailed 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) 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, all participants will return for recurrent laboratory assessment (chemistry, hematology and iron indices) at Day 21 (± 7) after each course of investigational treatment. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (≥18 years of age) able to provide informed consent.
  2. Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 4 weeks with no dose changes in heart failure drugs during the last 2 weeks.
  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 ≤35% obtained during the screening visit OR either of the following i. Historical value of ejection fraction ≤35% within 12 months of screening visit ii. Historical value of ejection fraction ≤25% within 24 months of screening visit

  5. Hemoglobin >9.0 g/dL and <13.5 g/dL (females) or <15.0 g/dL (males).
  6. Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.
  7. Either documented hospitalization for heart failure within 12 months of enrollment or screening visit N-terminal-pro-brain natriuretic peptide (NT-proBNP) >600 pg/ml (or BNP >200 pg/mL) for patients with normal sinus rhythm or NT-proBNP >1000 pg/ml (or BNP >400 pg/mL) for patients with atrial fibrillation. NOTE: NT-proBNP must be used to confirm eligibility for patients taking sacubitril/valsartan.

Exclusion Criteria:

  1. Current or planned oral iron supplementation. Iron-containing multivitamins (<30 mgs /day) are permitted.
  2. Known hypersensitivity reaction to any component of FCM.
  3. History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.
  4. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months of enrollment.
  5. Uncorrected severe aortic stenosis, severe valvular regurgitation, or left ventricular outflow obstruction requiring intervention.
  6. Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest).
  7. Current or planned mechanical circulatory support or heart transplantation.
  8. Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
  9. Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).
  10. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
  11. Known gastrointestinal bleeding. Patients with screening ferritin <15ng/ml must have an appropriate evaluation within 3 months of screening.
  12. 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.
  13. Inability to return for follow up visits within the necessary windows
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037931


Contacts
Contact: Todd Koch 610-650-4200 HEART-FID@luitpold.com
Contact: Mark Falone, MD 610-650-4200 HEART-FID@luitpold.com

  Show 116 Study Locations
Sponsors and Collaborators
Luitpold Pharmaceuticals
Duke Clinical Research Institute
Investigators
Study Chair: Adrian F Hernandez, MD Duke Clinical Research Institute
  More Information

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03037931     History of Changes
Other Study ID Numbers: 1VIT15043
First Submitted: January 25, 2017
First Posted: January 31, 2017
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics