Actively Recruiting
Effect of Oral Sucrosomial Iron on Exercise Capacity and Quality of Life in Patients With Heart Failure: a Randomized, Placebo-Controlled Trial (RISE-HF)
Led by Raffaele De Caterina · Updated on 2025-10-01
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
R
Raffaele De Caterina
Lead Sponsor
U
University of Pisa
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) who also have iron deficiency (ID). This study aims to determine if oral sucrosomial iron improves exercise ability, measured by the six-minute walk test, and quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, compared to a placebo. Patients included have left ventricular ejection fraction (LVEF) less than 50% and iron deficiency defined by transferrin saturation below 20%. Participants will be randomly assigned to receive either oral sucrosomial iron or a placebo. The sucrosomial iron is given once daily with added vitamin C to help absorption, with dosage based on hemoglobin levels and body weight, over 24 weeks. The placebo pills match the active treatment in appearance and dosing schedule but lack sucrosomial iron and vitamin C. This is a phase 4, quadruple-blind study comparing these two groups. Throughout the study, participants will undergo assessments including the six-minute walk test and quality of life questionnaires at 12 and 24 weeks. Additional evaluations include bone metabolism, iron levels, oxidative stress, heart function measures, and clinical event tracking. Safety and effectiveness will be monitored closely, with the primary outcomes focused on exercise distance and quality of life improvements after 12 weeks of treatment.
CONDITIONS
Brief Title
Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with chronic heart failure (NYHA class II-IV) and stable for at least 4 weeks
- Left ventricular ejection fraction less than 50%
- Hospitalization for heart failure in past 12 months or elevated NT-proBNP or BNP levels
- Transferrin saturation below 20%
- Hemoglobin between 10.0 and 16.0 g/dL
- No clinical need for rapid intravenous iron treatment
- Willing and able to provide informed consent
- Agree to use contraception to avoid pregnancy during the study
You will not qualify if you...
- Neuromuscular, orthopedic, or other non-cardiac conditions preventing exercise testing
- Participation in exercise training within 3 months before or planned during study
- Recent acute coronary events or stroke within 3 months
- Severe valvular or restrictive heart disease or acute myocarditis
- Atrial fibrillation/flutter with resting heart rate over 100 bpm
- Fever above 38°C or active infection needing antimicrobials
- Blood transfusion needed within last month
- Hemoglobin below 10 or above 16 g/dL
- Need for intravenous iron considered necessary
- Active gastrointestinal bleeding
- Use of oral or intravenous iron or erythropoietin in last 3 months
- Severe kidney disease or on hemodialysis
- Chronic liver disease with elevated liver enzymes
- Active cancer
- Iron overload with ferritin above 400 ng/mL
- Allergy to study products
- Participation in another clinical trial
- Low body weight (35 kg or less)
- Pregnancy or breastfeeding
- Use of forbidden medications
- Consumption of iron-rich or vitamin C rich foods altering iron absorption
- Conditions impairing intestinal iron absorption such as gastrectomy or coeliac disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive daily oral sucrosomial iron or placebo to assess effects on exercise capacity and quality of life.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy, 56124
Actively Recruiting
Research Team
G
Gabriele Masini, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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