RESAFE
An Open Label,Single-center, Non-interventional Prospective Study to Determine the Efficacy of Iron Therapy Using Intravenous Ferric Carboxymaltose and Its Effect in Reducing Arrhythmic Events in Participants With Iron Deficiency and HFrEF
Sponsor study identifier
observational
106
1 country
1
Study Start
June 20, 2019
Actual (reported)Primary Completion
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
An open label,single-center, non-interventional prospective study with the aim on investigating the effect of intravenous ferric carboxymaltose in restoring iron status and reducing the risk of severe arrhythmic events in participants with iron deficiency and a reduced ejection fraction (HFrEF).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 20, 2019
Actual (reported)July 5, 2021
Actual (reported)July 23, 2021
Actual (reported)August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Hemoglobin
Measured in g/dL, will be aggregated to form a composite primary endpoint of hemoglobin ≥ 12g/dL, plasma ferritin ≥ 50 ng/mL and transferrin saturation \> 20%
6 and 12 months
Ferritin
Measured in ng/mL, will be aggregated to form a composite primary endpoint of hemoglobin ≥ 12g/dL, plasma ferritin ≥ 50 ng/mL and transferrin saturation \> 20%
6 and 12 months
Transferrin saturation
Measured as a percentage, will be aggregated to form a composite primary endpoint of hemoglobin ≥ 12g/dL, plasma ferritin ≥ 50 ng/mL and transferrin saturation \> 20%
6 and 12 months
HF-related hospitalizations
6 and 12 months
N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
6 and 12 months
Kansas City Cardiomyopathy Questionnaire
6 and 12 months
EQ-5D-5L
6 and 12 months
Ventricular tachycardias recorded by cardiac implantable electronic device
6 and 12 months
HFrEF patients undergoing iron therapy with intravenous carboxymaltose (FCM). FCM administered dosage as per clinical routine. FCM administration is repeated no sooner than 3 months than last therapy, based on repeat ferritin and transferrin saturation levels.
Intravenous ferric carboxymaltose for the treatment of iron deficiency in HFrEF as per 2016 European Society of Cardiology Heart Failure guidelines.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with heart failure and reduced ejection fraction, cardiac implantable electronic devices and iron deficiency visiting the outpatient HF clinic of the Third Department of Cardiology AUTh
Hippokration General Hospital of Thessaloniki, Third Department of Cardiology (Aristotle University of Thessaloniki)
Thessaloniki, Macedonia, GR54642, Greece
Vassilios P Vassilikos, PhD
Hippokration General Hospital of Thessaloniki, Third Department of Cardiology, AUThi
106 participants (actual enrollment reported by the registry).
First Submitted
July 5, 2021
First Posted
July 23, 2021
Study Start
June 20, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 23, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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