Actively Recruiting
Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure
Led by Raffaele De Caterina · Updated on 2025-10-01
60
Participants Needed
1
Research Sites
117 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
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.
CONDITIONS
Official 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
- Diagnosis of chronic heart failure (New York Heart Association class II-IV) and clinically stable for at least 4 weeks with no changes in heart failure medications
- Left ventricular ejection fraction less than 50% measured within 6 months prior to screening
- History of hospitalization for heart failure in the past 12 months or elevated NT-proBNP/BNP levels according to heart rhythm
- Transferrin saturation less than 20%
- Hemoglobin levels between 10.0 and 16.0 g/dL
- Intravenous iron treatment not considered necessary by physician after medical record review
- Willingness to provide informed consent
- Use of single or dual contraceptive methods to prevent pregnancy during the study period
You will not qualify if you...
- Neuromuscular, orthopedic, or other non-cardiac conditions preventing exercise testing
- Participation in exercise training programs within 3 months before or planned within 3 months after enrollment
- Recent (less than 3 months) acute coronary syndrome, coronary artery bypass, percutaneous coronary interventions, transient ischemic attack, or stroke
- Severe valvular disease, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, or acute myocarditis
- Atrial fibrillation or flutter with resting ventricular rate above 100 beats per minute
- Fever of 38 °C or higher or active infection requiring antimicrobial treatment
- Blood transfusion required within the last month
- Hemoglobin below 10 g/dL or above 16 g/dL
- Intravenous iron treatment considered necessary by physician after medical record review
- Documented active gastrointestinal bleeding
- Use of oral iron, intravenous iron, or erythropoietin stimulating agents within the last 3 months
- Estimated glomerular filtration rate below 15 mL/min or on hemodialysis
- Chronic liver disease or elevated liver enzymes above 3 times the normal limit
- Active cancer
- Evidence of iron overload (ferritin above 400 ng/mL)
- Known severe allergies or hypersensitivity to study products
- Participation in another clinical study
- Body weight 35 kg or less
- Known or planned pregnancy during the next 4 months
- Use of forbidden medications
- Breastfeeding
- Dietary restrictions including consumption of iron-rich foods or vitamin C rich foods
- Conditions impairing intestinal iron absorption such as prior gastrectomy, atrophic gastritis, bariatric surgery, or coeliac disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy, 56124
Actively Recruiting
Research Team
G
Gabriele Masini, MD PhD
CONTACT
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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