MedTrace Logo

ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF)

NCT05697211 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-07

No results posted yet for this study

Summary

This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure.

Conditions

  • Heart Failure, Left-sided
  • Anemia, Iron Deficiency

Interventions

DRUG

Ferric maltol 30 mg (Feraccru®)

In this trial Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects.

Sponsors & Collaborators

  • Norgine

    collaborator INDUSTRY

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Johann Bauersachs, Prof. Dr. · Hannover Medical School, Department of Cardiology and Angiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2025-01-08
Completion
2025-01-08

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT05697211 on ClinicalTrials.gov