Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure

NCT06270498 | Recruiting Phase 4

• 1 other identifier: 24811
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID). The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo. One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo.

Conditions

Chronic Heart Failure; Iron-deficiency; Left Ventricular Systolic Dysfunction

Keywords

heart failure; iron deficiency; sucrosomial iron

Outcome Measures

Primary Outcomes (2)

• Difference in six-minute walk test (6MWT) distance, expressed as meters

  12 weeks

• Difference in Kansan City Cardiomyopathy Questionnaire (KCCQ)-12 overall score

  12 weeks

Secondary Outcomes (28)

• Proportion of patients with 15 meters improvement in 6MWT distance (responders)

  12 weeks

• Proportion of patients with 5-point improvement in KCCQ-12 score (responders)

  12 weeks

• Difference in six-minute walk test (6MWT) distance, expressed as meters

  24 weeks

• Difference in Kansan City Cardiomyopathy Questionnaire (KCCQ)-12 overall score

  24 weeks

• Proportion of patients with 15 meters improvement in 6MWT distance (responders)

  24 weeks

Other Outcomes (2)

• Adverse events and allergic reactions

  12 weeks

• Adverse events and allergic reactions

  24 weeks

Study Arms (2)

Sucrosomial iron

ACTIVE COMPARATOR

Dietary Supplement: Sucrosomial iron

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Sucrosomial iron DIETARY_SUPPLEMENT

Sucrosomial iron with the addition at a fixed dose of vitamin C to promote iron absorption (SiderAL® Forte) will be administered orally once a day for 24 weeks. The dose regimen for all participants will be calculated according to the haemoglobin (Hb) levels at baseline evaluation and to patient's body weight as follows: Hb 14-16 g/dL: 1 tablet once a day, corresponding to 30 mg/daily, for 24 weeks; Hb 10-13.9 g/dL: 2 tablets once a day, corresponding to 60 mg/daily, for 24 weeks

Also known as: SiderAL Forte

Sucrosomial iron

Placebo OTHER

Placebo pills will be identical in shape, form and color of SI tablets; they will contain the same components of SiderAL Forte® except for sucrosomial iron and vitamin C. Placebo will be administered orally once a day for 3 months according to the same dose scheme in the intervention arm.

Placebo

Eligibility Criteria

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

You may qualify if:

• Chronic HF (New York Heart Association \[NYHA\] functional class II-IV) patients, on optimal therapy, and clinically stable for at least 4 weeks with no dose changes of HF drugs
• LVEF\<50% at screening visit (historical value can be used if performed within 6 months of screening visit)
• Either a documented hospitalization for HF in the previous 12 months of enrolment or an elevated NT-proBNP: ≥250 pg/mL (or BNP ≥75 pg/mL) for patients in normal sinus rhythm; ≥1,000 pg/mL (or BNP ≥400 pg/mL) for patients in atrial fibrillation
• TSAT \<20%
• Hemoglobin 10.0-16.0 g/dL
• Rapid iron repletion with intravenous iron is not considered a clinical necessity by physicians after reviewing patient medical record (if anaemia is present, its grade is no more than mild)
• Age ≥18 years, male and female
• Willingness to provide informed consent
• Subjects who decide to use single or dual contraceptive methods to avoid conceiving during the study period

You may not qualify if:

• Neuromuscular, orthopedic or other non-cardiac condition that prevents the patient from exercise testing
• Exercise training program in the previous 3 months, or planned in the next 3 months
• Recent (\<3 month) acute coronary syndrome, coronary artery bypass surgery, percutaneous coronary interventions, transient ischemic attack, or stroke
• Severe valvular disease, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, acute myocarditis
• Atrial fibrillation or flutter with a ventricular response rate of \&gt;100 beats per minute at rest
• Temperature ≤38 °C (oral or equivalent) or active infection as defined by current use of oral or intravenous antimicrobial agents
• Need for blood transfusion within the last month
• Hb\<10 g/dL or Hb\>16 g/dL
• Rapid iron repletion with intravenous iron is considered a clinical necessity by physicians after reviewing patient medical record
• Documented active gastrointestinal bleeding
• Oral iron, i.v. iron or erythropoietin stimulating agent within the last 3 months
• eGFR ≤15 mL/min or on hemodialysis
• Chronic liver disease and/or alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range
• Active cancer
• Evidence of iron overload (ferritin \>400 ng/mL)

Sponsors & Collaborators

• Raffaele De Caterina: lead
• University of Pisa: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56124, Italy

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Ventricular Dysfunction, Left; Heart Failure; Iron Deficiencies

Interventions

sucrosomial iron

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Gabriele Masini, MD PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

• Raffaele De Caterina, MD PhD

  University of Pisa

  STUDY DIRECTOR

Central Study Contacts

Gabriele Masini, MD PhD

CONTACT

0039 050996712; gabriele.masini@unipi.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair of Cardiology Division

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: February 21, 2024
• Study Start: March 14, 2024
• Primary Completion: March 14, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

IT (1)