CONFIRM-HF: Iron supplementation improved HF outcomes

BARCELONA, Spain — Iron supplementation improved functional capacity, symptoms and quality of life in iron-deficient patients with HF, according to the results of the CONFIRM-HF study.

Researchers randomly assigned 304 patients at 41 sites across nine European countries to IV iron, given as ferric carboxymaltose solution (median total dose, 1,500 mg), or saline placebo for 1 year. All patients had stable, symptomatic HF and iron deficiency, defined as serum ferritin level <100 ng/mL or, if transferrin saturation was less than 20%, 100 ng/dL to 300 ng/dL.

The primary outcome was change in 6-minute walk distance between baseline and 24 weeks. Secondary endpoints included changes to NYHA functional class, Patient Global Assessment, health-related quality of life and fatigue score at 6, 12, 24, 36 and 52 weeks, as well as the effect of iron on the rate of hospitalization for worsening HF.

Piotr Ponikowski, MD, PhD, from the department of heart diseases at Medical University and the department of cardiology at Clinical Military Hospital, both in Wroclaw, Poland, presented the results at ESC Congress. They were simultaneously published in European Heart Journal.

Ponikowski and colleagues found that at 24 weeks, the iron group had a least squares mean increase of 18 m in 6-minute walk distance vs. a least squares mean decrease of 16 m in 6-minute walk distance for the placebo group (difference, 33 ± 11 m; P=.002).

At 52 weeks, the treatment effect of iron was sustained (difference, 36 ± 11 m; P<.001) and consistent across all evaluated subgroups, according to Ponikowski and colleagues.

From 24 weeks on, the iron group had significant improvement in NYHA class (P<.001 at 52 weeks), Patient Global Assessment (P=.001 at 52 weeks), health-related quality of life (P=.01 at 52 weeks) and fatigue score, the researchers found.

Treatment with iron was associated with reduced risk for hospitalization for worsening HF (HR=0.39; 95% CI, 0.19-0.82), according to the researchers. They also found that the number of deaths and adverse events were similar between the groups.

“Iron deficiency has recently been reported as a frequent comorbidity in [HF] and has been associated with impaired functional capacity, poor quality of life and increased mortality, irrespective of the presence of anemia,” Ponikowski said in a press release. “Therefore, correction of iron deficiency itself should be considered an attractive therapeutic target in this population. The magnitude of the treatment effect of [iron supplementation] on [6-minute walk] distance is robust and clinically meaningful. In previous interventional studies, such beneficial effects have only been seen with cardiac resynchronization therapy.”

For more information:

Ponikowski P. Eur Heart J. 2014;doi:10.1093/eurheartj/ehu385.

Ponikowski P. Hot Line I. Cardiovascular Disease: Novel Therapies. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.

Disclosure: The study was funded by Vifor Pharma Ltd. Ponikowski reports receiving a research grant and honoraria from Vifor Pharma and consulting and speaking for Amgen and Vifor Pharma.