• Heart Failure
• Deficiency Disorders
• Cardiology Clinical Trials
• Cardiology

• Heart Failure
• Deficiency Disorders
• Cardiology Clinical Trials

A sustainable improvement in functional capacity, symptoms, and quality of life was shown in patients with symptomatic chronic heart failure (HF) and iron deficiency (ID) who were treated with intravenous (IV) ferric carboxymaltose (FCM) throughout 1 year, and this treatment may reduce the risk of hospitalizations due to worsening HF, stated Piotr Ponikowski, MD, Medical University, Wroclaw, Poland, who presented the results of A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency [CONFIRM-HF; Ponikowski P et al. Eur Heart J. 2014].

ID is found in ≥ 50% of patients with H F, regardless of left ventricular ejection fraction (LVEF) or hospitalization status, and it is unrelated to the presence or absence of anemia. HF complicated with ID is associated with poor outcomes and increased mortality. The CONFIRM-HF trial was designed to determine the long-term sustainability of beneficial effects and safety and the potential impact of treatment with FCM on outcomes.

The double-blind trial conducted in 9 European countries randomized patients with NYHA class II and class III H F, LVEF ≤ 45%, brain natriuretic peptide (BNP) > 100 pg/ml, serum ferritin < 100 ng/ml or 100 to 300 ng/mL if transferrin saturation levels were < 20%, and hemoglobin < 15 g/dL to placebo (normal saline) or IV FCM. Blinding of patients was achieved by using black syringes and curtains, and there were blinded and unblinded clinical staff. In the correction phase, FCM (up to 2000 mg) was administered at baseline and week 6. In the maintenance phase, if ID was not corrected, FCM (500 mg) was administered at weeks 12, 24, and 36.

Of the 304 randomized patients, 150 in the FCM group and 151 in the placebo group comprise the full analysis set. The patients were representative of daily clinical practice: They were an average age of 70 years, 45% to 49% were women, around 50% were NYHA class II and III, and LVEF was approximately 37%. All patients were receiving optimal medical therapy for congestive HF. The mean ferritin level was 57 ng/mL, and close to 90% had a ferritin level < 100 ng/mL. The baseline 6-minute walk test (6MWT) distance was 288 m and 309 m in the FCM and placebo groups, respectively.

The primary end point of change in the 6MWT at week 24 was + 18 m with FCM and −16 m with placebo, resulting in an improvement of 33 m with FCM vs placebo (least squares mean; P = .002). At weeks 36 and 52, the 6MWT improved to an additional 42 m and 36 m, respectively, with FCM vs placebo (P < .001). The improvement in the primary end point was seen among all prespecified subgroups, representing the entire spectrum of HF, stated Prof Ponikowski.

The secondary end points measuring quality of life, including the Kansas City Cardiomyopathy Questionnaire and European Quality of Life 5D questionnaire, were improved early with FCM vs placebo and sustained at week 52. Hospitalization due to worsening HF was significantly reduced with FCM compared with placebo.

The secondary end points of self-reported Patient Global Assessment (PGA) score and NYHA class improved early and were sustained at week 52. The odds ratio for PGA was > 1 at week 6 and week 52 with FCM vs placebo (P = .29 and P = .001, respectively). The odds ratio for change in NYHA class was > 1 at week 6 and week 52 (P = .067 and P < .001, respectively).

Dr Ponikowski concluded that treatment of iron deficiency with FCM in symptomatic HF patients resulted in sustained improvement in functional capacity, symptoms, and quality of life and resulted in a reduction in HF hospitalizations.

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