A Study to Evaluate Injectafer® as Treatment for Heart Failure with Iron Deficiency

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-002595
    NCT ID: NCT03037931
    Sponsor Protocol Number: 1VIT15043

About this 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 iron deficiency and with a reduced ejection fraction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Adult ≥ 18 years of age.
  • Able to provide 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:
      • Historical value of ejection fraction ≤ 40% within 24 months of screening visit;
      • 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 elevated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization:
    • For patients in normal sinus rhythm: N-terminal-probrain natriuretic peptide (NT-proBNP) >600 pg/mL (or BNP > 200 pg/mL);
    • For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP > 400 pg/mL.
      • NOTE: NT-proBNP must be used to confirm eligibility for patients taking sacubitril/valsartan.

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, 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 an investigational product.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Margaret Redfield, M.D.

Open for enrollment

Contact information:

Amanda Biddle R.N.

7785428

Biddle.Amanda@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20357887

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