Evidence map›Paper›PMID 38896006›Full record

Trial reportEuropean journal of heart failure2025

Characterization of serum phosphate levels over time with intravenous ferric carboxymaltose versus placebo as treatment for heart failure with reduced ejection fraction and iron deficiency: An exploratory prospective substudy from HEART-FID.

Nina Nouhravesh, Jyotsna Garg, Frank W Rockhold, Carmine G De Pasquale, Eileen O'Meara, Gregory D Lewis, Javed Butler, Josephine Harrington, Justin A Ezekowitz, Piotr Ponikowski and 7 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in European journal of heart failure, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Iron therapy & restless legs syndrome: a narrative review.Sleep & breathing = Schlaf & Atmung · 2026
    Review
  2. Article
  3. Article
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  5. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Nina NouhraveshDuke Clinical Research Institute, Durham, NC, USA.
Jyotsna GargDuke Clinical Research Institute, Durham, NC, USA.
Frank W RockholdDuke Clinical Research Institute, Durham, NC, USA.
Carmine G De PasqualeFlinders Medical Centre, Adelaide, SA, Australia.
Eileen O'MearaMontreal Heart Institute and Université de Montréal, Quebec, Canada.
Gregory D LewisDivision of Cardiology, Massachusetts General Hospital, Boston, MA, USA.
Javed ButlerDepartment of Medicine, University of Mississippi, Jackson, MS, USA.
Josephine HarringtonDuke Clinical Research Institute, Durham, NC, USA.
Justin A EzekowitzCanadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.
Piotr PonikowskiThe Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.
Richard W TroughtonDepartment of Medicine, Christchurch Heart Institute, University of Otago, Christchurch, New Zealand.
Yee Weng WongDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
Nicole BlackmanAmerican Regent, Shirley, NY, USA.
Syed NumanAmerican Regent, Shirley, NY, USA.
Robert AdamczykAmerican Regent, Shirley, NY, USA.
Adrian F HernandezDuke Clinical Research Institute, Durham, NC, USA.
Robert J MentzDuke Clinical Research Institute, Durham, NC, USA.

Funding

TRANSFORM-HF CCCU01HL125511 · NHLBI · YALE UNIVERSITY · PI MENTZ, ROBERT JOHN, VELAZQUEZ, ERIC J · 2017 to 2021
$7.7M
Postdoctoral Training in Cardiovascular Clinical ResearchT32HL069749 · NHLBI · DUKE UNIVERSITY · PI MARK, DANIEL B · 2003 to 2023
$6.7M
American RegentAmerican Regent, a Daiichi Sankyo Group companyNHLBI NIH HHS T32 HL069749NHLBI NIH HHS U01 HL125511
6 · The paper itself

Abstract

aimsFerric carboxymaltose (FCM) is guideline-recommended for iron deficiency (ID) in heart failure with reduced ejection fraction (HFrEF). Despite a well-established safety profile, the magnitude and clinical significance of FCM-induced hypophosphataemia in HFrEF remains unclear. This pre-specified substudy of HEART-FID evaluated serum phosphate, 1,25-dihydroxyvitamin D, and plasma parathyroid hormone (PTH) subsequent to FCM. METHODS AND

resultsHEART-FID was a randomized, double-blind, placebo-controlled trial of ambulatory patients with HFrEF and ID randomized to FCM versus placebo. This substudy assessed mean change from baseline across eight visits over 6 months for the following endpoints: serum phosphate, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, and PTH, in addition to the clinical severity of potential hypophosphataemia. Overall, 133 patients (n = 62 FCM, n = 71 placebo) were prospectively enrolled. Mean age was 68 ± 11 years, 55 (41.4%) were women, and 29 (21.8%) had chronic kidney disease. Phosphate levels decreased in 34 (57.6%) patients in the FCM group compared with 7 (10.3%) in the placebo group. Mean change in phosphate levels reached a nadir at day 21 (-0.36 ± 0.27 mmol/L) subsequent to FCM infusion with 28 (51%) having moderate-to-severe hypophosphataemia. Reductions in 1,25-dihydroxyvitamin D were also observed, whilst PTH increased. These biochemical changes returned to baseline levels by day 91. Serum levels of 25-hydroxyvitamin D remained stable throughout the study. No serious adverse events associated with hypophosphataemia were reported.

conclusionsTransient moderate-to-severe hypophosphataemia was frequent subsequent to FCM infusion, accompanied by 1,25-dihydroxyvitamin D decrease and PTH increase. Serum levels of 25-hydroxyvitamin D remained stable. No evidence of symptomatic hypophosphataemia was reported, collectively indicating FCM-related hypophosphataemia to be clinically benign and transient in HFrEF.

Indexed as

Anemia, Iron-DeficiencyFerric CompoundsHeart FailureHypophosphatemiaMaltosePhosphatesStroke VolumeAgedDouble-Blind MethodFemaleHumansIron DeficienciesMaleMiddle AgedParathyroid HormoneProspective Studies1,25-dihydroxyvitamin D25-hydroxyvitamin Dferric carboxymaltoseFerric CompoundsMaltoseParathyroid HormonePhosphatesVitamin DFerric carboxymaltoseHeart failure with reduced ejection fractionHypophosphataemia

Identifiers

PMID38896006
PMCPMC11655705

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.