Trials / Completed
CompletedNCT02937454
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency
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)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,132 (actual)
- Sponsor
- Vifor (International) Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)
Detailed description
This is a randomised, double-blind, placebo-controlled Trial (RCT). The 52 weeks observation period following randomisation is considered appropriate to investigate the primary endpoint of recurrent HF hospitalisations and CV death. To evaluate the effect of intravenous ferric carboxymaltose (IV FCM) in iron deficient subjects with AHF, subjects will be enrolled during a hospital stay (Index hospitalisation) after the acute care treatment of the index event has been stabilised. All subjects will continue to receive their established standard therapy for HF and medical emergencies will be treated according to local routine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ferric carboxymaltose | 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 |
| OTHER | Normal saline 0.9% | Normal saline will be administered as a bolus injection. |
Timeline
- Start date
- 2017-04-03
- Primary completion
- 2020-07-21
- Completion
- 2020-07-21
- First posted
- 2016-10-18
- Last updated
- 2021-06-18
- Results posted
- 2021-06-18
Locations
16 sites across 15 countries: Argentina, Brazil, Croatia, Georgia, Israel, Italy, Lebanon, Netherlands, Poland, Romania, Singapore, Spain, Sweden, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02937454. Inclusion in this directory is not an endorsement.