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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Chronic Heart Failure, Iron-deficiency, Left Ventricular Systolic Dysfunction

In brief

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.

Key facts

Study ID

NCT06270498

Run by

Raffaele De Caterina

People needed

60

Starts

2024-03-14

Expected to finish

2026-06-14

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• Hypersensitivity to any of the study products or known severe allergies
• Participation in another study
• Low body weight (≤35 kg)
• Known or anticipated pregnancy in the next 4 months
• Need for forbidden medications
• Breastfeeding
• Consumption of iron-rich foods or any food that alter iron absorption (i.e. food rich in vitamin C) due to dietary requirements
• Any pathological condition or disease associated with a reduction or an impairment of intestinal iron absorption (i.e., prior gastrectomy, atrophic gastritis, bariatric surgery, coeliac disease)

Where it is running

• Azienda Ospedaliero Universitaria Pisana — Pisa, Tuscany, Italy (enrolling)

Full record on ClinicalTrials.gov

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