Ferinject Assessment in Patients With Iron Deficiency and Chronic Heart Failure - FAIR-HF

Nov 17, 2009
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Vifor Pharma
Date Presented:
01/01/2009
Date Published:
01/01/2009
Date Updated:
11/17/2009
Original Posted Date:
11/17/2009
References

Description:

The goal of this trial was to compare treatment with intravenous iron compared with placebo among patients with chronic heart failure and iron deficiency (with or without anemia).

Hypothesis:

Intravenous iron would improve symptoms and quality of life.

Study Design

  • Placebo Controlled
  • Randomized
  • Blinded
  • Parallel

Patients Enrolled: 459
Mean Follow Up: 24 weeks
Mean Patient Age: 68 years
Female: 52%
Mean Ejection Fraction: 32%

Patient Populations:

  • Patients with chronic heart failure (LVEF 40% or less with NYHA class II functional capacity or LVEF 45% or less with NYHA class III functional capacity)
  • Iron deficiency (ferritin level <100 µg/L or 100-299 µg/L if transferrin saturation <20%)
  • Hemoglobin between 9.5 and 13.5 g/dl

Exclusions:

  • Uncontrolled hypertension
  • Other clinically significant heart disease
  • Significant liver or renal disease
  • Inflammation

Primary Endpoints:

  • Self-reported Patient Global Assessment at 24 weeks
  • NYHA functional class at 24 weeks

Secondary Endpoints:

  • Distance walked in 6 minutes
  • Health-related quality of life

Drug/Procedures Used:

Patients with chronic heart failure and iron deficiency (with or without anemia) were randomized to intravenous iron (ferric carboxymaltose) (n = 304) versus placebo (n = 155).

In the iron group, patients received 200 mg of intravenous iron weekly until iron stores were repleted, then every 4 weeks for a total of 24 weeks.

Concomitant Medications:

At baseline in the iron group, the use of diuretic was 92%, angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker 92%, beta-blocker 86%, antiplatelet therapy 62%, and lipid-lowering therapy 47%.

Principal Findings:

Overall, 459 patients were randomized. In the intravenous iron group, the mean age was 68 years, 52% were women, mean left ventricular ejection fraction (LVEF) was 32%, 31% had diabetes, and 55% had a prior myocardial infarction. The mean hemoglobin was 11.9 g/dl in the iron group and 11.9 g/dl in the placebo group. Serum ferritin was 52.5 µg/L and 60.1 µg/L, respectively.

The primary outcome, Patient Global Assessment at 24 weeks, was reported as much or moderately improved in 50% of the intravenous iron group versus 28% of the placebo group (p < 0.001). New York Heart Association (NYHA) class I or II at 24 weeks was 47% versus 30% (p < 0.001), respectively. Results were the same irrespective of the presence of anemia. Significant improvement was seen in the distance on a 6-minute walk test (p < 0.001).

Death was 3.4% versus 5.5% (p = 0.47), first hospitalization was 17.7% versus 24.8% (p = 0.30), hospitalization for any cardiovascular cause was 10.4% versus 20.0% (p = 0.08), any cardiac disorder reported as an adverse event was 27.6% versus 50.2% (p = 0.01), and any gastrointestinal disorder reported as an adverse event was 16.9% versus 6.9% (p = 0.06), respectively. At follow-up, mean hemoglobin was 13.0 g/dl versus 12.5 g/dl (p < 0.001), respectively.

Interpretation:

Among patients with chronic heart failure and iron deficiency (with or without anemia), the use of intravenous iron for 24 weeks was beneficial. This therapy resulted in improved symptoms, functional capacity, and quality of life. This benefit was the same in tested subgroups, such as presence of anemia. Intravenous iron appeared to have a favorable safety profile. Hospitalization for any cardiovascular cause trended towards being reduced by iron therapy. Further study is needed to determine if this strategy can translate into improved clinical outcomes.

References:

Anker SD, Colet JC, Filippatos G, et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009;Nov 17:[Epub ahead of print].

Presented by Dr. Stefan Anker at the American Heart Association Scientific Sessions, Orlando, FL, November 17, 2009.

Keywords: Iron, Myocardial Infarction, Follow-Up Studies, Maltose, Ferric Compounds, Hemoglobins, Ferritins, Transferrins, Quality of Life, Heart Failure, Stroke Volume, Diabetes Mellitus


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