At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,132 enrolled
Drug / intervention
ferric carboxymaltose +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.
A Randomised, Double-Blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Patients Admitted for Acute Heart Failure (Affirm-AHF)
In Brief
A Phase 4 clinical trial evaluating ferric carboxymaltose and Normal saline 0.9% for Iron Deficiency and Heart Failure. Completed, enrolled 1,132 participants across 16 sites in 15 countries.
Detailed Summary
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency, Heart Failure
CountriesArgentina, Brazil, Croatia, Georgia, Israel, Italy, Lebanon, Netherlands, Poland, Romania, Singapore, Spain, Sweden, Ukraine, United Kingdom
CollaboratorsWorldwide Clinical Trials, Cytel Inc.
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartApr 2017
Primary CompletionJul 2020
TodayJul 2026
First PostedOct 18, 2016
Enrollment StartApr 3, 2017
Primary CompletionJul 21, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.7 years ago
Interventions
ferric carboxymaltosedrug
FCM will be administered as an undiluted bolus injection. The study treatment dose (mL) to be administered will be determined by the patient's body weight and haemoglobin (Hb) value at the respective visits where study treatment will be administered
Normal saline 0.9%other
Normal saline will be administered as a bolus injection.