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Randomized Controlled Trial
. 2019 Aug;6(4):621-628.
doi: 10.1002/ehf2.12462. Epub 2019 May 30.

Effect of ferric carboxymaltose on calculated plasma volume status and clinical congestion: a FAIR-HF substudy

Darlington O Okonko  1   2 , Fadi Jouhra  2 , Huda Abu-Own  2 , Gerasimos Filippatos  3 , Josep Comin Colet  4   5 , Chainey Suki  6 , Claudio Mori  6 , Piotr Ponikowski  7 , Stefan D Anker  8   9 ; FAIR-HF Investigators
Affiliations
Randomized Controlled Trial

Effect of ferric carboxymaltose on calculated plasma volume status and clinical congestion: a FAIR-HF substudy

Darlington O Okonko et al. ESC Heart Fail. 2019 Aug.

Abstract

Aims: Iron deficiency worsens symptoms, quality of life, and exercise capacity in chronic heart failure (CHF) and might do so by promoting fluid retention. We assessed whether iron repletion improved congestion in CHF and appraised the prognostic utility of calculated plasma volume status (PVS), a novel index of congestion, in the FAIR-HF data set.

Methods and results: In FAIR-HF, 459 iron deficient CHF patients were randomized to intravenous ferric carboxymaltose (FCM) or saline and assessed at 4, 12, and 24 weeks. Using weight and haematocrit, we calculated PVS in 436 patients. At baseline, PVS and weight were -5.5 ± 7.7% and 76.9 ± 14.3 kg, with peripheral oedema evident in 35% of subjects. Higher PVS values correlated to other congestion surrogates such as lower serum albumin. At 4 weeks, FCM was associated with greater reductions in weight (0.02) and PVS (P < 0.0001), and a trend for improved peripheral oedema at 24 weeks (0.07). Irrespective of treatment allocation, patients with a decrease in PVS from baseline to week 24 had higher increments in 6 min walking distance (61.4 m vs. 43.5 m, 0.02) and were more likely to improve their NYHA class (33.3% vs. 15.5%, 0.001). A PVS > -4% at baseline predicted worse outcomes even after adjustment for treatment assignment (hazard ratio 1.88, 95% confidence interval 1.01-3.51, 0.046).

Conclusions: Intravenous iron therapy with FCM is associated with early reductions in PVS and weight, implying that decongestion might be one mechanism via which iron repletion aids CHF patients. Calculated PVS is of prognostic utility in this cohort.

Keywords: Congestion; Iron; Oedema; Plasma volume.

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Conflict of interest statement

The FAIR‐HF trial was supported by Vifor Pharma, Glattbrugg, Switzerland. All authors had full access to the study data, decided to submit the report for publication, and assume responsibility for the completeness and accuracy of the data, and the content and integrity of the report. C.M. and S.C. are employees of Vifor. D.O.O. has received speaker's fees and research support from Vifor and Pharmacosmos. S.D.A. has received fees for consulting and/or speaking from Bayer, Boehringer Ingelheim, Novartis, Servier, and Vifor. S.D.A. has received research grants from Abbott Vascular and Vifor. G.P. is a member of Committees in trials and registries sponsored by Vifor, Novartis, Bayer, and Servier. P.P. has received consulting and speaker's fees and research grants from Vifor.

Figures

Figure 1
Figure 1
Distribution of plasma volume status (PVS) in FAIR‐HF.
Figure 2
Figure 2
Change in markers of congestion in FAIR‐HF. Alterations from baseline to week 24 in PVS (A), Hct (B), weight (C), and peripheral oedema (D) are shown. A total of 372, 371, and 309 patients had data for analysis at weeks 4, 12, and 24, respectively. ANOVA, analysis of variance; FCM, ferric carboxymaltose; PVS, plasma volume status.
Figure 3
Figure 3
Baseline PVS categories (≤−4% vs. >−4%) and survival. PVS, plasma volume status.
See this image and copyright information in PMC

References

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