CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,105 enrolled
Drug / intervention
Iron +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03036462
NCT03036462Phase 4Completed
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Ferric Carboxymaltose Assessment of Morbidity and Mortality in Patients With IRon Deficiency and Chronic Heart Failure

Universitätsklinikum Hamburg-Eppendorf·interventional·Posted Jan 30, 2017·Updated Jan 28, 2025

In Brief

A Phase 4 clinical trial evaluating Iron and Saline for Systolic Heart Failure and Iron Deficiency. Completed, enrolled 1,105 participants across 51 sites in 7 countries.

Detailed Summary

The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) extends the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death and reduces hospitalisation and mortality in patients with iron deficiency and heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystolic Heart Failure, Iron Deficiency
CountriesGermany, Hungary, Italy, Poland, Portugal, Slovenia, Spain
CollaboratorsDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Charite University, Berlin, Germany

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 30, 2017
Enrollment StartMar 7, 2017
Primary CompletionMay 2, 2024
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 9.4 years ago

Interventions

Irondrug

i.v. iron administration

Salinedrug

i.v. NaCl administration