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

Launched by UNIVERSITY OF PADOVA · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of vitamin D combined with a type of oral iron supplement called sucrosomial iron in patients who have heart failure and low iron levels. The main goal is to see if this combination is as effective as an intravenous iron treatment in helping improve symptoms of heart failure, particularly how far patients can walk in six minutes, after 24 weeks of treatment.

To participate in this trial, individuals should be between 18 and 80 years old and have a specific type of heart failure (NYHA class II or III) which means they have some limitations in their activities due to symptoms. They also need to have recently been stable in their heart failure treatment and show signs of low iron and vitamin D levels. Throughout the trial, participants will have regular check-ups and tests every six weeks to monitor their health and any side effects. It's important to know that people with certain conditions, like recent heart surgery or severe liver disease, won't be eligible to join.

Gender

ALL

Eligibility 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.