Iron uptake in patients with heart failure and iron deficiency.

Ferroglycine Sulfate Absorption in patients with Heart Failure and Iron Deficency: an interventional before and after study. - The Iron Abs Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000158-21-SE

Enrollment

Registered

2017-02-06

Start date

2017-04-13

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure with Iron Deficiency MedDRA version: 20.0 Level: LLT Classification code 10022977 Term: Iron deficiency anemia, unspecified System Organ Class: 100000004851 MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849

Interventions

Trade Name: Niferex Product Name: Ferroglycin Sulfate Pharmaceutical Form: Capsule INN or Proposed INN: Ferroglycine Sulfate CAS Number: 14729-84-1 Other descriptive name: FERROUS (II) GLYCINE SULFATE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Heart Failure. Separate groups for patients with ejection fraction above or belowe 45% • Iron deficiency defined as Ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • Gastroenterological disease or operation • Acute or chronic inflammatory or infectious disease • Hematological disease • Kidney dysfunction with GFR <30 ml/min. • Hemocromatosis. • Premenopausal women • Diabetes mellitus with insulin treatment. • Known hypersensitivity to the active substance or to any of the components • On going iron treatment or blood transfusion within the las 30 days. • Age <18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to study if heart failure with iron deficiency is associated with reduced iron absorption.;Secondary Objective: Not applicable;Primary end point(s): Iron concentration in plasma;Timepoint(s) of evaluation of this end point: Two hours after drug administration.	—

Secondary

Measure	Time frame
Secondary end point(s): Transferrinsaturation i plasma;Timepoint(s) of evaluation of this end point: Two hours after drug administration.	—

Countries

Sweden

Contacts

Public ContactClinical Trial Information

Karolinska Institutet

46852480000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 28, 2026