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RECRUITING
NCT06270498
PHASE4

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

Sponsor: Raffaele De Caterina

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-03-14

Completion Date

2026-06-14

Last Updated

2025-10-01

Healthy Volunteers

No

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.

Locations (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy