Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic Heart Failure and Iron Deficiency

• Status: Not yet recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this randomized, controlled, open-label, interventional study is to evaluate whether, in patients with heart failure (HF) and iron deficiency (ID), the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of HF.

The main hypothesis which the study aims to test is the non-inferiority of sucrosomial iron (± vitamin D) compared with FCM treatment, after 24 weeks. Primary endpoint: the performance of the Six-Minute Walking Test, comparing the mean difference from baseline of the distance walked by patients in meters.

Participants will be evaluated in outpatient scheduled visits at 6, 12 and 24 weeks, performing blood tests, clinical evaluation, instrumental investigations and recording any adverse events, cardiovascular events, re-hospitalizations and fractures.

The study will involve randomization into 3 groups with a 1:1:1 ratio:

1. Control group [standard of care]: administration of FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on body weight and hemoglobin values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible additional administration of 500 mg at week 12 in case of persistent ID.

2. Sucrosomial iron group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once a day for 24 weeks.

3. Sucrosomial iron and vitamin D group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily + vitamin D3 (100,000 IU load at time 0, then 2,000 IU daily) for 24 weeks

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova
• Treatments: Vitamin D

Criteria

Inclusion Criteria:

NYHA functional class II-III due to symptomatic chronic HF and all the following:

• At least 3 weeks since the last hospitalization or emergency department access for acute HF decompensation.

• Optimal drug treatment for HF according to the European Society of Cardiology guidelines determined by the investigator (unless contraindications or treatment not tolerated).

• No changes in HF therapy dosage in the previous 2 weeks (except diuretics).

• No new HF therapy in the 3 weeks prior to recruitment.

• LVEF ≤45%.

• Brain Natriuretic Peptide (BNP) >100 pg/mL and/or NT-proBNP >400 pg/mL at pre-recruitment evaluation.

• Evidence of ID defined as ferritin <100 ng/ml or TSAT <20% in case of ferritin levels between 100 and 300 ng/ml.

• 25-OH-Vitamin D levels <50 nmol/L.

• The subject must be able to complete the 6MWT.

• At least 18 years of age.

Exclusion Criteria:

• Myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke, coronary artery bypass, percutaneous intervention, or major thoracic or cardiac surgery within the previous 2 months.

• Clinically relevant (severe) non-corrected valvular heart disease, obstructive cardiomyopathy.

• Chronic anemia due to non-correctable causes other than ID and anemia of chronic disease (e.g., hemoglobinopathies, hematologic malignancies, hemolytic anemia).

• Anemia due to Vitamin B12 or acid folic deficiency. Recruitment may be re-evaluated at least 6 weeks after the end of vitamin B12 and or folic acid supplementation.

• History of acquired iron overload.

• Administration of erythropoietin, iron supplementation (either oral or intravenous iron), blood transfusion in the previous 6 weeks or already scheduled for the 3 months after recruitment.

• Administration of vitamin D or similar in the 3 months preceding or already scheduled for the 3 months following recruitment.

• Severe bone disease.

• Active infections, C-reactive protein (CRP) >20 mg/L, clinically significant bleeding, active neoplasm (with exception of basal cell or squamous cell carcinoma of the skin and intraepithelial cervical neoplasia).

• Chronic liver disease (including active hepatitis) and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x normal limit.

• Immunosuppressive therapy or dialysis.

• Pregnancy or breastfeeding.

• The subject has a known sensitivity to any of the products that will be administered during the study protocol.