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Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Chronic Heart Failure and Iron Deficiency
Open accessAbstract
Background: Iron deficiency is common in patients with heart failure (HF) and is associated with reduced exercise capacity and poor outcomes. Whether correction of iron deficiency with (intravenous) ferric carboxymaltose (FCM) affects peak oxygen consumption [peak V O 2 ], an objective measure of exercise intolerance in HF, has not been examined. Methods: We studied patients with systolic HF (left ventricular ejection fraction ≤45%) and mild to moderate symptoms despite optimal HF medication. Patients were randomized 1:1 to treatment with FCM for 24 weeks or standard of care. The primary end point was the change in peak V O 2 from baseline to 24 weeks. Secondary end points included the effect on hematinic and cardiac biomarkers, quality of life, and safety. For the primary analysis, patients who died had a value of 0 imputed for 24-week peak V O 2 . Additional sensitivity analyses were performed to determine the impact of imputation of missing peak V O 2 data. Results: A total of 172 patients with HF were studied and received FCM (n=86) or standard of care (control group, n=86). At baseline, the groups were well matched; mean age was 64 years, 75% were male, mean left ventricular ejection fraction was 32%, and peak V O 2 was 13.5 mL/min/kg. FCM significantly increased serum ferritin and transferrin saturation. At 24 weeks, peak V O 2 had decreased in the control group (least square means −1.19±0.389 mL/min/kg) but was maintained on FCM (−0.16±0.387 mL/min/kg; P =0.020 between groups). In a sensitivity analysis, in which missing data were not imputed, peak V O 2 at 24 weeks decreased by −0.63±0.375 mL/min/kg in the control group and by −0.16±0.373 mL/min/kg in the FCM group; P =0.23 between groups). Patients’ global assessment and functional class as assessed by the New York Heart Association improved on FCM versus standard of care. Conclusions: Treatment with intravenous FCM in patients with HF and iron deficiency improves iron stores. Although a favorable effect on peak V O 2 was observed on FCM, compared with standard of care in the primary analysis, this effect was highly sensitive to the imputation strategy for peak V O 2 among patients who died. Whether FCM is associated with an improved outcome in these high-risk patients needs further study. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01394562.
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McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab670 · Cited by 19,442
Self-citation2013 ACCF/AHA Guideline for the Management of Heart Failure
Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Drazner, M. H., Fonarow, G. C., Geraci, S. A., Horwich, T., Januzzi, J. L., et al. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2013.05.019 · Cited by 12,536
2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
Ponikowski, P., Voors, A. A., Anker, S. D., Bueno, H., Cleland, J. G. F., Coats, A. J. S., Falk, V., González-Juanatey, J. R., Harjola, V.-P., Jankowska, E. A., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw128 · Cited by 11,429
Self-citationYancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Drazner, M. H., Fonarow, G. C., Geraci, S. A., Horwich, T., Januzzi, J. L., et al. (2013) · Circulation · doi:10.1161/cir.0b013e31829e8776 · Cited by 2,106
Ferric Carboxymaltose in Patients with Heart Failure and Iron Deficiency
Anker, S. D., Comin Colet, J., Filippatos, G., Willenheimer, R., Dickstein, K., Drexler, H., Lüscher, T. F., Bart, B., Banasiak, W., Niegowska, J., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0908355 · Cited by 2,083
Self-citationPonikowski, P., van Veldhuisen, D. J., Comin-Colet, J., Ertl, G., Komajda, M., Mareev, V., McDonagh, T., Parkhomenko, A., Tavazzi, L., Levesque, V., et al. (2015) · European Heart Journal · doi:10.1093/eurheartj/ehu385 · Cited by 1,242
Self-citationWRITING COMMITTEE MEMBERS, Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Colvin, M. M., Drazner, M. H., Filippatos, G., Fonarow, G. C., et al. (2016) · Circulation · doi:10.1161/cir.0000000000000435 · Cited by 897
Iron deficiency in chronic heart failure: an international pooled analysis
Klip, I. T., Comin-Colet, J., Voors, A. A., Ponikowski, P., Enjuanes, C., Banasiak, W., Lok, D. J., Rosentryt, P., Torrens, A., Polonski, L., et al. (2013) · American Heart Journal · doi:10.1016/j.ahj.2013.01.017 · Cited by 736
Current and Potential Therapeutic Strategies for Hemodynamic Cardiorenal Syndrome
Obi, Y., Kim, T., Kovesdy, C. P., Amin, A. N., & Kalantar-Zadeh, K. (2016) · Cardiorenal Medicine · doi:10.1159/000441283 · Cited by 614
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Cited by
McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab670 · Cited by 19,442
Self-citation2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure
McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab368 · Cited by 13,344
Self-citationEzekowitz, J. A., O'Meara, E., McDonald, M. A., Abrams, H., Chan, M., Ducharme, A., Giannetti, N., Grzeslo, A., Hamilton, P. G., Heckman, G. A., et al. (2017) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2017.08.022 · Cited by 676
Self-citationHeart failure with preserved ejection fraction: from mechanisms to therapies
Lam, C. S. P., Voors, A. A., de Boer, R. A., Solomon, S. D., & van Veldhuisen, D. J. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehy301 · Cited by 355
Self-citationGrote Beverborg, N., Klip, I. T., Meijers, W. C., Voors, A. A., Vegter, E. L., van der Wal, H. H., Swinkels, D. W., van Pelt, J., Mulder, A. B., Bulstra, S. K., et al. (2018) · Circulation Heart Failure · doi:10.1161/circheartfailure.117.004519 · Cited by 278
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Metadata
- Authors
- van Veldhuisen, D. J., Ponikowski, P., van der Meer, P., Metra, M., Böhm, M., Doletsky, A., Voors, A. A., Macdougall, I. C., Anker, S. D., Roubert, B., Zakin, L., & Cohen-Solal, A.
- Venue
- Circulation
- Published
- 2017-10-10
- Volume
- 136
- Issue
- 15
- Pages
- 1374-1383
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2734960411
- Cited by
- 423
- References
- 28
- FWCI
- 22.08
- Type
- journal article
- Language
- en
- Open access
- green
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- van Veldhuisen, D. J., Ponikowski, P., van der Meer, P., Metra, M., Böhm, M., Doletsky, A., Voors, A. A., Macdougall, I. C., Anker, S. D., Roubert, B., Zakin, L., & Cohen-Solal, A. (2017). Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Chronic Heart Failure and Iron Deficiency. Circulation. https://doi.org/10.1161/circulationaha.117.027497
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