Effect of Administering Ferric Carboxymaltose on Quality of Life in Heart Failure Patients

Methodology and Course of the Study, Evaluated Patient Population

Patients over 18 years of age hospitalized with symptoms of acute heart failure and a concurrent rise in characteristic biomarkers were included in the double-blind placebo-controlled study. All patients had a left ventricular ejection fraction (LVEF) < 50%, received at least 40 mg of intravenous furosemide daily, and suffered from iron deficiency, defined as a serum ferritin level < 100 ng/ml or between 100 and 299 ng/ml with a transferrin saturation < 20%.

Patients were divided into two groups. One group received ferric carboxymaltose (FCM) with the dosage determined by hemoglobin values and body weight, while the other group received a placebo. The initial dose was administered at discharge from the hospital, followed by a subsequent dose at the 6th week of follow-up (more than 1000 mg FCM or placebo). If iron deficiency persisted, patients received another two doses at the 12th and 24th weeks (500 mg FCM or placebo).

The primary parameters evaluated were rehospitalization for symptomatic heart failure and cardiovascular mortality. Additionally, the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score was monitored, where patients evaluated symptoms and physical condition (KCCQ-12 CSS) and independence and quality of life (KCCQ-12 OSS). This variant of the questionnaire contained a total of 12 questions, with an alternative version consisting of 23 questions, which is considerably more time-consuming. The questionnaire was presented to patients at the 2nd, 4th, 6th, 12th, 24th, 36th, and 52nd weeks of follow-up. To simplify interpretation of the questionnaire results, the outcomes were presented on a scale from 0 to 100 points, where 0 indicated the most severe manifestations and limitations, and 100 points indicated an excellent quality of life without clinical symptoms of heart failure.

Results

Out of a total of 1058 patients, 535 received ferric carboxymaltose and 523 received a placebo. In both groups, an increase in KCCQ-12 OSS was observed in the first two weeks (+18.5 ± 1.2 points in the FCM group and +17.2 ± 1.2 points in the placebo group), with no statistically significant difference (p = 0.277). From the 4th to the 24th week of follow-up, significantly greater improvement in KCCQ-12 OSS was observed in the FCM group (+2.9; 95% confidence interval [CI] 0.5–5.3; p = 0.018 at the 4th week and +3.0; 95% CI 0.3–5.6; p = 0.028 at the 24th week), with the differences being statistically significant.

The results were similar in the questionnaire independently assessing heart failure symptoms (KCCQ-12 CSS). In the first two weeks, the FCM and placebo groups were almost identical (+20.94 ± 1.18 points in the FCM group and +20.10 ± 1.21 points in the placebo group); greater improvement was again observed in the FCM group by the 24th week (+2.9; 95% CI 0.2–5.6; p = 0.035). At the 52nd week of follow-up, the treatment effect was still present, but the increase in questionnaire scores OSS and CSS was not as pronounced (+1.44; 95% CI –1.45 to +4.33), or +0.63 (95% CI –2.21 to +3.47).

Discussion and Conclusion

According to the results of the AFFIRM-AHF study, there was an improvement in health-related quality of life in all iron-deficient patients discharged after stabilization following an acute heart failure episode. Patients receiving intravenous ferric carboxymaltose achieved higher points indicating an increased HRQoL compared to those receiving a placebo, particularly between the 4th and 24th week of follow-up. A slight improvement persisted even at the 52nd week. The increase in HRQoL in the first weeks for patients receiving a placebo was likely due to the intensification of heart failure therapy during hospitalization.

It is evident that heart failure must be viewed as a highly complex clinical entity with a wide range of symptoms, and the physician must also consider other comorbidities recorded in a particular patient. An essential and primary goal of therapy for heart failure with reduced ejection fraction is the reduction of symptoms and improvement in condition and quality of life. As indicated by the study results, interventions with proven positive effects include the intravenous administration of ferric carboxymaltose.

(kali)

Source: Jankowska E. A., Kirwan B., Kosiborod M. The effect of intravenous ferric carboxymaltose on health-related quality of life in iron-deficient patients with acute heart failure: the results of the AFFIRM-AHF study. Eur Heart J 2021 Jun 3; 42 (31): 3011−3020, doi: 10.1093/eurheartj/ehab234.