Status:
COMPLETED
Changes in Myocardial Iron After Iron Administration
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Conditions:
Heart Failure
Iron-deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Recent studies have shown that treatment with intravenous iron in patients with iron deficiency (ID) and heart failure with reduced ejection fraction (HFrEF) improves symptomatology, functional capaci...
Eligibility Criteria
Inclusion
- Patients with ambulatory chronic heart failure
- Older than 18 years
- Patients in NYHA class II-III on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of HF drugs during the last 2 weeks (with the exception of diuretics)
- Elevated natriuretic peptides levels (NT-proBNP \>400 pg/ml) at the screening visit
- Left ventricle ejection fraction \<50% documented in the last 12 months
- Iron deficiency defined as: serum ferritin level \<100 μg/L or ferritin level 100-299 μg/L when TSAT is less than 20%, and hemoglobin \<15 g/dL (all at screening)
- Participant is willing and able to give informed consent for participation in the study
Exclusion
- Known sensitivity to any of the products to be administered per protocol.
- History of acquired iron overload.
- Severe valve disease, or being scheduled for cardiac surgery within the next 30 days.
- Acute myocardial infarction or acute coronary syndrome, transient ischemic attack, or stroke within the last 3 months prior to randomization.
- Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization.
- Ischemic heart disease scheduled for revascularization procedures within the next 30 days.
- HF scheduled for cardiac resynchronization therapy within the next 30 days.
- Patients with active bleeding in the last 30 days.
- Known active infection or active malignancy.
- Subject at an immediate need of transfusion or hemoglobin ≥15 g/dL.
- Anemia due to reasons other than iron deficiency
- Immunosuppressive therapy or renal dialysis
- History of erythropoietin, intravenous iron therapy, and blood transfusion in the previous 12 weeks.
- Oral iron therapy at doses \>100 mg/day in previous 1 week prior to randomization.
- Subjects with an immediate need for transfusion.
- Pregnant or breastfeeding women.
- Subject of childbearing potential who is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
- Subject currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study, or subject is receiving other investigational agent(s).
- Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2018
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03398681
Start Date
May 1 2017
End Date
July 30 2018
Last Update
July 30 2019
Active Locations (6)
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1
Hospital General de Castellón
Castellon, Castellón, Spain
2
Hospital de Manises
Manises, Valencia, Spain
3
ERESA
Valencia, Spain, 46010
4
Fundación Investigación Hospital Clínico Universitario de Valencia. Instituto de Investigación Sanitaria INCLIVA.
Valencia, Spain, 46010