Kurzfassung

Congestive heart failure (CHF) is a condition with high mortality and morbidity. CHF represents an emerging epidemic and constitutes an increasing challenge for western health care systems. Prevalence in Germany lies around 3 %, resulting in 2.5 million patients. According to guidelines, prognosis-relevant therapy is limited to beta-blockers, ACE-inhibitors or ARBs, and aldosterone-antagonists. As evidenced by national Medicare hospital claims, two years after first hospitalization 50%, and 6...Congestive heart failure (CHF) is a condition with high mortality and morbidity. CHF represents an emerging epidemic and constitutes an increasing challenge for western health care systems. Prevalence in Germany lies around 3 %, resulting in 2.5 million patients. According to guidelines, prognosis-relevant therapy is limited to beta-blockers, ACE-inhibitors or ARBs, and aldosterone-antagonists. As evidenced by national Medicare hospital claims, two years after first hospitalization 50%, and 6 years after first hospitalization 75% of all CHF patients have died. The poor prognosis for heart failure patients underscores the importance of treatment modalities that can prevent, improve, or reverse myocardial dysfunction, particularly for the growing number of adults who are at increased risk for developing heart failure because of uncontrolled hypertension, diabetes, or after myocardial infarction. Of note, half of CHF patients suffer from anemia, and in three out of four cases, anemia is caused by iron deficiency.

In the FAIR-HF trial, patients with systolic heart failure and iron deficiency who were treated with the injectable iron preparation ferric carboxymaltose (ferinject®, Vifor Pharma) responded over 24 weeks with significantly improved symptoms, NYHA functional class, six-minute-walk distance, and quality of life, whether or not they also had anemia. Interestingly a steady state effect was achieved already after 12 weeks, which probably represents the fastest-acting separation ever seen in a heart-failure clinical trial. The benefits of iron therapy were consistent in all subgroup analyses, including those by sex, age, renal function, NYHA class, LVEF, heart-failure etiology, diabetes status, and body-mass index, and most notably by hemoglobin level and median ferritin level. 

The project aims to further establish the short-term, high-dosage iron-supplementation in CHF-patients with iron-deficiency. In contrast to FAIR-HF, this study will evaluate a hard, clinically relevant primary endpoint, the change in LV-EF 12 weeks after iron supplementation with the most objective technique. Therefore, all patients will undergo cardiac-MRI at baseline and at follow-up -12 weeks after supplementation of the calculated iron deficiency at (up to a maximum of 1000 mg at once). In addition, we will evaluate a wide range of secondary endpoints, including multiple biomarkers and GFR, since sub-analysis of FAIR-HF revealed an improvement of renal function in the verum group. Since impaired renal function represents one of the most important prognostic parameters of CHF, each patient will undergo a routine GFR determination with the state-of-the-art technique of radionuclide Chromium-51-EDTA measurement, both at baseline and at follow-up after 12 weeks.» weiterlesen» einklappen