[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536874":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":37,"locations":42,"responsibleParty":61,"collaborators":65,"id":67,"slug":11,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":11,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Azienda Ospedaliero, Universitaria Pisana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sucrosomial iron","ACTIVE_COMPARATOR",null,[13],"Dietary Supplement: Sucrosomial iron",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"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.\n\nThe 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:\n\nHb 14-16 g\u002FdL: 1 tablet once a day, corresponding to 30 mg\u002Fdaily, for 24 weeks; Hb 10-13.9 g\u002FdL: 2 tablets once a day, corresponding to 60 mg\u002Fdaily, for 24 weeks",[9],[25],"SiderAL Forte",{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":11},"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.\n\nPlacebo will be administered orally once a day for 3 months according to the same dose scheme in the intervention arm.",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Gabriele Masini, MD PhD","University of Pisa","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":32,"role":36},"Raffaele De Caterina, MD PhD","STUDY_DIRECTOR",[38],{"name":31,"role":39,"phone":40,"phoneExt":11,"email":41},"CONTACT","0039 050996712","gabriele.masini@unipi.it",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Azienda Ospedaliero Universitaria Pisana","RECRUITING","Pisa","Tuscany","56124","Italy",{"type":51,"coordinates":52},"Point",[53,54],10.4036,43.70853,{"lat":54,"lon":53},[57,59],{"name":58,"role":39,"phone":11,"phoneExt":11,"email":11},"Gabriele Masini, MD, PhD",{"name":60,"role":39,"phone":11,"phoneExt":11,"email":11},"SImona Chiusulo, MD, PhD",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Raffaele De Caterina","Chair of Cardiology Division",[66],{"name":32,"class":6},"100536874",false,"NCT06270498","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)","RISE-HF","Inclusion Criteria:\n\n1. 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\n2. LVEF\\\u003C50% at screening visit (historical value can be used if performed within 6 months of screening visit)\n3. Either a documented hospitalization for HF in the previous 12 months of enrolment or an elevated NT-proBNP: ≥250 pg\u002FmL (or BNP ≥75 pg\u002FmL) for patients in normal sinus rhythm; ≥1,000 pg\u002FmL (or BNP ≥400 pg\u002FmL) for patients in atrial fibrillation\n4. TSAT \\\u003C20%\n5. Hemoglobin 10.0-16.0 g\u002FdL\n6. 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)\n7. Age ≥18 years, male and female\n8. Willingness to provide informed consent\n9. Subjects who decide to use single or dual contraceptive methods to avoid conceiving during the study period\n\nExclusion Criteria:\n\n1. Neuromuscular, orthopedic or other non-cardiac condition that prevents the patient from exercise testing\n2. Exercise training program in the previous 3 months, or planned in the next 3 months\n3. Recent (\\\u003C3 month) acute coronary syndrome, coronary artery bypass surgery, percutaneous coronary interventions, transient ischemic attack, or stroke\n4. Severe valvular disease, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, acute myocarditis\n5. Atrial fibrillation or flutter with a ventricular response rate of \\>100 beats per minute at rest\n6. Temperature ≤38 °C (oral or equivalent) or active infection as defined by current use of oral or intravenous antimicrobial agents\n7. Need for blood transfusion within the last month\n8. Hb\\\u003C10 g\u002FdL or Hb\\>16 g\u002FdL\n9. Rapid iron repletion with intravenous iron is considered a clinical necessity by physicians after reviewing patient medical record\n10. Documented active gastrointestinal bleeding\n11. Oral iron, i.v. iron or erythropoietin stimulating agent within the last 3 months\n12. eGFR ≤15 mL\u002Fmin or on hemodialysis\n13. Chronic liver disease and\u002For alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range\n14. Active cancer\n15. Evidence of iron overload (ferritin \\>400 ng\u002FmL)\n16. Hypersensitivity to any of the study products or known severe allergies\n17. Participation in another study\n18. Low body weight (≤35 kg)\n19. Known or anticipated pregnancy in the next 4 months\n20. Need for forbidden medications\n21. Breastfeeding\n22. Consumption of iron-rich foods or any food that alter iron absorption (i.e. food rich in vitamin C) due to dietary requirements\n23. 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)","ALL","18 Years",{"count":77,"type":78},60,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","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).\n\nThe 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.\n\nOne group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo.",[84,85,86],"Chronic Heart Failure","Iron-deficiency","Left Ventricular Systolic Dysfunction",[88,89,90],"heart failure","iron deficiency","sucrosomial iron","2025-09-25",{"date":93,"type":94},"2025-10-01","ACTUAL",{"date":96,"type":94},"2024-03-14",{"date":98,"type":78},"2026-06-14",{"name":63,"class":6},1]