A Phase 4 interventional study of Sucrosomial iron and Placebo in Chronic Heart Failure, Iron-deficiency and Left Ventricular Systolic Dysfunction, sponsored by Raffaele De Caterina. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Raffaele De Caterina · Phase 4, Interventional, and Treatment
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.
Based on clinical trials, treatment with intravenous iron improves symptoms, exercise capacity, and may reduce HF hospitalizations in patients with HF and ID. On the contrary, treatment of ID with oral iron has no effect on exercise capacity. High hepcidin levels prevent oral intestinal absorption and blunt the response to oral iron administration. Sucrosomial iron (SI) consists of a nucleus of ferric pyrophosphate with an envelope of sucrose ester of fatty acids, which promotes intestinal absorption through paracellular and lymphatic routes, independent of hepcidin. In contrast with intravenous iron infusion, administration of oral iron may not promote oxidative stress, since the intestinal iron absorption prevent the formation of labile, non-transferrin bound, plasma iron.
The study will investigate the effect of oral SI supplementation on exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo in patients with HF, a left ventricular ejection fraction (LVEF) \<50%. Iron deficiency was defined as transferrin saturation (TSAT) \<20%.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Raffaele De Caterina is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Sucrosomial iron
Other: Placebo
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
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.
Difference in six-minute walk test (6MWT) distance, expressed as meters
Time frame: 12 weeks
Difference in Kansan City Cardiomyopathy Questionnaire (KCCQ)-12 overall score
Time frame: 12 weeks
Proportion of patients with 15 meters improvement in 6MWT distance (responders)
Time frame: 12 weeks
Proportion of patients with 5-point improvement in KCCQ-12 score (responders)
Time frame: 12 weeks
Difference in six-minute walk test (6MWT) distance, expressed as meters
Time frame: 24 weeks
Difference in Kansan City Cardiomyopathy Questionnaire (KCCQ)-12 overall score
Time frame: 24 weeks
Proportion of patients with 15 meters improvement in 6MWT distance (responders)
Time frame: 24 weeks
Proportion of patients with 5-point improvement in KCCQ-12 score (responders)
Time frame: 24 weeks
Bone metabolism indices
Change in phosphate and FGF-23
Time frame: 12 weeks
Bone metabolism indices
Change in phosphate and FGF-23
Time frame: 24 weeks
Iron indices
Change in TSAT, ferritin and serum iron
Time frame: 12 weeks
Iron indices
Change in TSAT, ferritin and serum iron
Time frame: 24 weeks
Oxidative stress
Change in F2-isoprostanes, Soluble NOX2-derived peptide and H2O2
Time frame: 12 weeks
Oxidative stress
Change in F2-isoprostanes, Soluble NOX2-derived peptide and H2O2
Time frame: 24 weeks
Iron indices 2
change in soluble receptor of transferrin and hepcidin
Time frame: 12 weeks
Iron indices 2
change in soluble receptor of transferrin and hepcidin
Time frame: 24 weeks
Systolic cardiac function
Change in Left ventricular ejection fraction, %
Time frame: 12 weeks
Systolic cardiac function
Change in left ventricular ejection fraction, %
Time frame: 24 weeks
NTproBNP
Change in NT-proBNP
Time frame: 12 weeks
NTproBNP
Change in NT-proBNP
Time frame: 24 weeks
Clinical events
Time to death or to first HF hospitalization
Time frame: 12 weeks
Clinical events
Time to death or to first HF hospitalization
Time frame: 24 weeks
Left atrial volume
Change in left atrial volume
Time frame: 12 weeks
Left ventricular volume
Change in left ventricular end-diastolic volume
Time frame: 12 weeks
Left ventricular diastolic function
change in E/e' ratio
Time frame: 12 weeks
Echocardiographic estimation of pulmonary pressure
change in systolic pulmonary artery pressure
Time frame: 12 weeks
Left atrial volume
Change in left atrial volume
Time frame: 24 weeks
Left ventricular diastolic function
change in E/e' ratio
Time frame: 24 weeks
Echocardiographic estimation of pulmonary pressure
change in systolic pulmonary artery pressure
Time frame: 24 weeks
Left ventricular volume
Change in left ventricular end-diastolic volume
Time frame: 24 weeks
Adverse events and allergic reactions
Number of any adverse events and number of allergic reactions
Time frame: 12 weeks
Adverse events and allergic reactions
Number of any adverse events and number of allergic reactions
Time frame: 24 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Mar 2026, 24 months after the start.
Of 43 non-industry phase 4 interventional studies under Anemia, Iron-Deficiency, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 35. This study's planned 24 months is above that.
Counting every sponsor, half of 51 studies reached it within 22 months; a quarter within 15 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Sucrosomial iron
Raffaele De Caterina