Treatment of iron deficiency in HF improves functional capacity and quality of life
Presented during ESC Congress 2014 by: Piotr PONIKOWSKI (Wroclaw, PL)
Effect of ferric carboxymaltose on functional capacity in patients with heart failure and iron deficiency (CONFIRM-HF)
BackgroundIron is very important for normal functioning and survival of organisms. Iron deficiency is a frequent comorbidity in patients with heart failure (HF) and in patients admitted to hospital for worsening HF. HF complicated by iron deficiency is associated with reduced functional capacity, poor quality of life and increased mortality, independent of anemia. Correcting iron deficiency is an attractive therapeutic target in HF.
The CONFIRM-HF study (Ferric CarboxymaltOse evaluatioN on perFormance in patients with IRon deficiency in coMbination with chronic Heart Failure) is a randomized, double-blind, controlled, phase 4 study evaluating the efficacy and safety of intravenous iron carboxymaltose (FCM) compared with placebo in 304 patients with chronic heart failure and iron deficiency (serum ferritin <100 ng/ml, or between 100 and 300 ng/mL as transferrin saturation <20%). The purpose of this study is to measure the effect of iron suppletion on the exercise capacity of this group of patients. The difference between the 6-minute walk test at baseline and at week 24 was the primary endpoint.
- With FCM, the six-minute walk test was improved after 24 weeks by 33 ± 11 meters (least square mean ± SE, P=0.002) compared to placebo.
- Secondary analyses of changes in patient-reported Patient Global Assessment (PGA) score and NYHA class also showed improvements in FCM compared to placebo, from 12 and 24 weeks treatment, respectively.
- The improvement in distance covered during the 6-minute walk test was stable between 24 and 52 weeks after randomization.
- The incidence of hospitalizations for worsening HF was lower in FCM-treated patients compared to patients receiving placebo (7.6 events vs. 19.4 events per 100 patient years of risk, HR: 0.39, 95% CI: 0.19-0.82, P=0.009 ).
- Mortality did not differ from placebo after one year iron depletion (HR: 0.89, 95% CI: 0.41-1.93, P=0.77).
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ConclusionsIn symptomatic patients with chronic heart failure and iron deficiency, treatment with iron-carboxymaltose during a year resulted in ongoing improvements in functional capacity, symptoms and quality of life. Possibly this treatment also reduces the risk of recurrent admission for worsening HF.
During the press conference, Dr. Ponikowski already wondered whether this improvement in 6-minute walk test is a clinically relevant improvement. He answered this question by stating that this kind of improvements were up to now only seen with cardiac resynchronization therapy. In addition, patients themselves indicate that they feel better, and NYHA class and quality of life improved.
Dr. Ponikowski emphasized that iron deficiency is an unsung comorbidity; it is not monitored well enough, although this is recommended in the ESC guideline. This trial shows that iron deficiency is a significant co-morbidity, which can be easily detected. Treatment can easily yield an improvement of functional capacity and probably even outcomes.
- Our reports are based on information made available at the ESC congress -
This data was published in Eur H Journal on August 31.