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Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

NCT03036462 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1105

Last updated 2025-01-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Iron

i.v. iron administration

DRUG

Saline

i.v. NaCl administration

Sponsors & Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Mahir Karaks, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2024-05-02
Completion
2024-05-02

Countries

  • Germany
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Slovenia
  • Spain

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 NCT03036462 on ClinicalTrials.gov