Iron uptake in patients with heart failure and iron deficiency.
- Conditions
- Chronic Heart Failure with Iron DeficiencyMedDRA version: 20.0Level: LLTClassification code 10022977Term: Iron deficiency anemia, unspecifiedSystem Organ Class: 100000004851MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-000158-21-SE
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
•Heart Failure. Separate groups for patients with ejection fraction above or belowe 45%
•Iron deficiency defined as Ferritin < 100 ug/L , or Ferritin 100-299 ug/L and transferrinsaturation <20%.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Transferrinsaturation i plasma;Timepoint(s) of evaluation of this end point: Two hours after drug administration.