RecruitingPhase 4NCT06270498

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

Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure: a Randomized, Placebo-controlled Trial (RISE-HF)

Sponsor

Raffaele De Caterina

Enrollment

60 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

Iron-deficiency Chronic Heart Failure Left Ventricular Systolic Dysfunction

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an oral iron supplement (sucrosomial iron, which is easier on the stomach than traditional iron pills) can improve exercise capacity and quality of life in people with heart failure who also have low iron levels. **You may be eligible if...** - You have chronic heart failure with reduced heart pumping function - Your iron levels are low (transferrin saturation below 20%) - Your hemoglobin is between 10 and 16 g/dL - Your condition has been stable for at least 4 weeks **You may NOT be eligible if...** - Your doctor believes you urgently need intravenous iron - Your heart failure has been unstable recently - You have severe kidney disease or other significant health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSucrosomial iron

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

OTHERPlacebo

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.

Locations(1)

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

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NCT06270498

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