December 27, 2023Open Access
Iron deficiency in heart failure with preserved ejection fraction: rationale and design of the FAIR-HFpEF trial
Key Result
The FAIR-HFpEF trial was designed to evaluate intravenous ferric carboxymaltose in HFpEF with iron deficiency, but enrollment was terminated early after 42 patients due to the COVID-19 pandemic.
Study Design
Type
RCT (n=42)
Blinding
Double-blind
Randomization
1:1
Multicenter
Yes
Structured PICO
Does intravenous ferric carboxymaltose improve exercise capacity in patients with heart failure with preserved ejection fraction and iron deficiency?
P
Population
Patients with heart failure with preserved ejection fraction (HFpEF), reduced exercise capacity, and iron deficiency (defined as serum ferritin <100 ng/mL or serum ferritin 100-299 ng/mL with transferrin saturation <20%)
I
Intervention
Intravenous ferric carboxymaltose (FCM) at doses aimed to replenish iron stores
C
Comparator
Placebo
O
Outcome
Difference in exercise capacity from baseline to week 24 as assessed by the 6-minute walk testsurrogate
The FAIR-HFpEF trial is designed to evaluate whether intravenous iron repletion with ferric carboxymaltose improves exercise capacity in patients with HFpEF and iron deficiency.
Limitations
- Enrollment was terminated early after 42 patients due to recruitment difficulties and the COVID-19 pandemic
- Only male patients with LVEF ≤40% were included (as stated in the text's limitations section, though contradictory to the HFpEF design)
- Small sample size in matching analysis
- Follow-up was not analyzed to determine if body composition and muscle strength alterations lead to worse long-term outcomes
- Cannot exclude differences in peak VO2 correction between cycle ergometer and treadmill
Abstract
Background: Iron deficiency is highly prevalent in patients with heart failure and has well established diagnostic criteria. Its occurrence is associated with reduced quality of life, exercise capacity and increased hospitalization rates and mortality. The clinical efficacy of treating iron deficiency has not been tested in patients with heart failure with preserved ejection fraction (HFpEF). Methods: The FAIRHFpEF trial aims to enroll patients with HFpEF, reduced exercise capacity and iron deficiency (defined as serum ferritin <100 ng/mL or serum ferritin 100299 ng/mL with transferrin saturation <20%). Patients will be treated in a multicenter, doubleblind, randomized clinical trial with intravenous ferric carboxymaltose (FCM) at doses aimed to replenish iron stores vs. placebo. The primary endpoint is the difference in exercise capacity from baseline to week 24 as assessed by the 6minute walk test. Secondary endpoints include healthrelated quality of life assessments such as the Kansas City Cardiomyopathy Questionnaire, the European Quality of Life5 Dimensions questionnaire and global function tests. Conclusions: The FAIRHFpEF trial is designed to investigate the effect of intravenous iron repletion in iron deficient patients with HFpEF using FCM.
Cite This Study
Haehling et al. (Wed,) conducted a rct in Heart failure with preserved ejection fraction (HFpEF) and iron deficiency (n=42). Intravenous ferric carboxymaltose (FCM) vs. Placebo (normal saline: 0.9% w/v NaCl) was evaluated on Change in exercise capacity from baseline to week 24 as assessed by the 6-minute walk test distance (6MWTD). The FAIR-HFpEF trial was designed to evaluate intravenous ferric carboxymaltose in HFpEF with iron deficiency, but enrollment was terminated early after 42 patients due to the COVID-19 pandemic.