Trial · NCT03037931

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

NCT03037931, Phase 3, Completed, American Regent, Inc.; results first posted 2024-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study. Trials, record NCT03037931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03037931

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
NCT number: NCT03037931
Status: Completed
Phases: Phase 3
Enrollment: 3,065 participants, actual
Lead sponsor: American Regent, Inc.
Conditions: Heart Failure, Iron-deficiency
Interventions: Ferric Carboxymaltose, Placebo
First posted: 2017-01-31
Last updated: 2024-07-03
Results first posted: 2024-07-03

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Deaths	1 year	The number of participants who died out of the total treated group.
Primary	Number of Hospitalizations for Heart Failure	1 year	The number of participants who were hospitalized for heart failure out of the total treated group.
Primary	Change in 6MWT (Six Minute Walk Test) Distance	6 months	The change in meters walked at baseline compared to 6 months later.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Deaths	1 year	Intent-to-treat Population	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Hospitalizations for Heart Failure	1 year	Intent-to-treat Population	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change in 6MWT (Six Minute Walk Test) Distance	6 months	Number of participants within the ITT population which contributed to the 6MWT data	unit of measure in meters	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Deaths	Ferric Carboxymaltose	131		Participants
Number of Deaths	Placebo	158		Participants
Number of Hospitalizations for Heart Failure	Ferric Carboxymaltose	297		Participants
Number of Hospitalizations for Heart Failure	Placebo	332		Participants
Change in 6MWT (Six Minute Walk Test) Distance	Ferric Carboxymaltose	8.179	Standard Deviation 59.963	unit of measure in meters
Change in 6MWT (Six Minute Walk Test) Distance	Placebo	3.979	Standard Deviation 58.896	unit of measure in meters

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ferric Carboxymaltose	1,532
Overall Study	STARTED	Placebo	1,533
Overall Study	COMPLETED	Ferric Carboxymaltose	1,123
Overall Study	COMPLETED	Placebo	1,121
Overall Study	NOT COMPLETED	Ferric Carboxymaltose	409
Overall Study	NOT COMPLETED	Placebo	412

Source ClinicalTrials.gov

Adverse events1,066

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Pneumonia	Infections and infestations	Ferric Carboxymaltose	57	1,532	64
other	Pneumonia	Infections and infestations	Placebo	35	1,533	37
other	COVID-19	Infections and infestations	Ferric Carboxymaltose	39	1,532	39
other	COVID-19	Infections and infestations	Placebo	37	1,533	39
other	Sepsis	Infections and infestations	Ferric Carboxymaltose	21	1,532	22
other	Sepsis	Infections and infestations	Placebo	13	1,533	14
other	Cellulitis	Infections and infestations	Ferric Carboxymaltose	12	1,532	12
other	Cellulitis	Infections and infestations	Placebo	21	1,533	27
other	COVID-19 pneumonia	Infections and infestations	Ferric Carboxymaltose	11	1,532	11
other	COVID-19 pneumonia	Infections and infestations	Placebo	17	1,533	17

1 to 10 of 1,066Source ClinicalTrials.gov

See all 1,066 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ferric Carboxymaltose	354	1,532
Total, all-cause mortality	Placebo	367	1,533
Total, other adverse events	Ferric Carboxymaltose	424	1,532
Total, other adverse events	Placebo	412	1,533
Total, serious adverse events	Ferric Carboxymaltose	413	1,532
Total, serious adverse events	Placebo	401	1,533

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34003690	DERIVED	PubMed
37598795	DERIVED	PubMed
37632463	DERIVED	PubMed
38250799	DERIVED	PubMed
39890013	DERIVED	PubMed
41137844	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ferric Carboxymaltose vs Placebo: Number of Deaths	Trial comparisons
Ferric Carboxymaltose vs Placebo: deaths from any cause	Trial comparisons
Ferric Carboxymaltose vs Placebo: Number of Hospitalizations for Heart Failure	Trial comparisons
Ferric Carboxymaltose vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03037931

GET https://conductscience.org/api/trials/v1/NCT03037931/events?page=2

API reference For AI assistants