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

PHASE4RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 14, 2024

Primary Completion Date

March 14, 2026

Study Completion Date

June 14, 2026

Conditions
Chronic Heart FailureIron-deficiencyLeft Ventricular Systolic Dysfunction
Interventions
DIETARY_SUPPLEMENT

Sucrosomial 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"

OTHER

Placebo

"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."

Trial Locations (1)

56124

RECRUITING

Azienda Ospedaliero Universitaria Pisana, Pisa

All Listed Sponsors
collaborator

University of Pisa

OTHER

lead

Raffaele De Caterina

OTHER