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

NCT05702970 | Unknown Phase 4 DMC

• 1 other identifier: VICTORID-HF
• Study Type: interventional
• Target: 258
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 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

Conditions

Heart Failure; Iron-deficiency; Heart Failure, Systolic; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Vitamin D Deficiency

Keywords

Heart Failure; Iron Deficiency; Sucrosomial Iron; Ferric Carboxymaltose; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of Six-Minute Walking Test (6MWT)

  To evaluate the change from baseline performance of the 6MWT, in the three treatment arms, measuring the distance walked by patients in meters

  24 weeks

Secondary Outcomes (38)

• Quality of life (QoL) assessment

  24 weeks

• Cardiovascular and general endpoint 1

  12 and 24 weeks

• Cardiovascular and general endpoint 2

  12 and 24 weeks

• Cardiovascular and general endpoint 3

  12 and 24 weeks

• Cardiovascular and general endpoint 4

  12 and 24 weeks

Study Arms (3)

Ferric Carboxymaltose

ACTIVE COMPARATOR

Control Group

Drug: Ferric Carboxymaltose 50 MG/ML

Sucrosomial iron

EXPERIMENTAL

Experimental arm 1

Drug: Sucrosomial iron

Sucrosomial iron and vitamin D

EXPERIMENTAL

Experimental arm 2

Drug: Sucrosomial iron; Drug: Vitamin D

Interventions

Sucrosomial iron DRUG

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

Also known as: SiderAl Forte

Sucrosomial iron; Sucrosomial iron and vitamin D

Vitamin D DRUG

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

Also known as: DiBase / UltraD3

Sucrosomial iron and vitamin D

Ferric Carboxymaltose 50 MG/ML DRUG

Control group \[standard of care\]: administration of FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on body weight and Hb 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.

Also known as: Ferinject

Ferric Carboxymaltose

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• OH-Vitamin D levels \<50 nmol/L.
• The subject must be able to complete the 6MWT.
• At least 18 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

MeSH Terms

Conditions

Heart Failure; Anemia, Iron-Deficiency; Heart Failure, Systolic; Vitamin D Deficiency; Iron Deficiencies

Interventions

sucrosomial iron; Vitamin D; ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Federico Capone, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

• Roberto Vettor, MD

  University of Padova

  STUDY DIRECTOR

Central Study Contacts

Roberto Vettor, MD

CONTACT

+39 0498211245; roberto.vettor@unipd.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients and examining physicians will be aware of the allocated arm, whereas, outcome analysts will be kept blinded to the treatment allocation arm. This will be accomplished by blinding the investigators assessing: NHYA class, distance walked at 6MWT, KCCQ, vital signs. Echocardiography data will be measured offline or by an independent physician, blinded to the treatment allocation. Events at follow-up will be assessed by an adjudication committee blinded to the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, randomized, controlled, open-label, sequential recruitment study

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 27, 2023
• Study Start: January 15, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 31, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-01