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Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients

NCT03662789 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-05-25

Study results available
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Summary

Iron deficiency is prevalent in heart transplant recipients, and may be associated with reduced functional capacity. The IronIC trial is designed to assess the effect of intravenous iron isomaltoside on exercise capacity, muscle strength, cognition and quality of life in iron-deficient heart transplant recipients

Conditions

  • Heart Transplant Recipients

Interventions

DRUG

Iron Isomaltoside 1000

Intravenous infusion

OTHER

Placebo: NaCl 0,9%

Intravenous infusion

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

  • Pharmacosmos A/S

    collaborator INDUSTRY

Principal Investigators

  • Lars Gullestad, MD, PhD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2020-02-27
Completion
2020-02-27

Countries

  • Norway

Study Locations

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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 NCT03662789 on ClinicalTrials.gov