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Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency

NCT02937454 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1132

Last updated 2021-06-18

Study results available
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Summary

Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)

Conditions

Interventions

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.

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Cytel Inc.

    collaborator INDUSTRY

  • Vifor (International) Inc.

    lead INDUSTRY

Principal Investigators

  • Piotr Ponikowski, MD · Medical University Clinical Military Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2020-07-21
Completion
2020-07-21

Countries

  • Argentina
  • Brazil
  • Croatia
  • Georgia
  • Israel
  • Italy
  • Lebanon
  • Netherlands
  • Poland
  • Romania
  • Singapore
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02937454 on ClinicalTrials.gov