NCT06270498 Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure
| NCT ID | NCT06270498 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Raffaele De Caterina |
| Condition | Chronic Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2026-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-03-14 with a primary completion date of 2026-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 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 2. LVEF\<50% at screening visit (historical value can be used if performed within 6 months of screening visit) 3. Either a documented hospitalization for HF in the previous 12 months of enrolment or an elevated NT-proBNP: ≥250 pg/mL (or BNP ≥75 pg/mL) for patients in normal sinus rhythm; ≥1,000 pg/mL (or BNP ≥400 pg/mL) for patients in atrial fibrillation 4. TSAT \<20% 5. Hemoglobin 10.0-16.0 g/dL 6. 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) 7. Age ≥18 years, male and female 8. Willingness to provide informed consent 9. Subjects who decide to use single or dual contraceptive methods to avoid conceiving during the study period Exclusion Criteria: 1. Neuromuscular, orthopedic or other non-cardiac condition that prevents the patient from exercise testing 2. Exercise training program in the previous 3 months, or planned in the next 3 months 3. Recent (\<3 month) acute coronary syndrome, coronary artery bypass surgery, percutaneous coronary interventions, transient ischemic attack, or stroke 4. Severe valvular disease, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, acute myocarditis 5. Atrial fibrillation or flutter with a ventricular response rate of \>100 beats per minute at rest 6. Temperature ≤38 °C (oral or equivalent) or active infection as defined by current use of oral or intravenous antimicrobial agents 7. Need for blood transfusion within the last month 8. Hb\<10 g/dL or Hb\>16 g/dL 9. Rapid iron repletion with intravenous iron is considered a clinical necessity by physicians after reviewing patient medical record 10. Documented active gastrointestinal bleeding 11. Oral iron, i.v. iron or erythropoietin stimulating agent within the last 3 months 12. eGFR ≤15 mL/min or on hemodialysis 13. Chronic liver disease and/or alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range 14. Active cancer 15. Evidence of iron overload (ferritin \>400 ng/mL) 16. Hypersensitivity to any of the study products or known severe allergies 17. Participation in another study 18. Low body weight (≤35 kg) 19. Known or anticipated pregnancy in the next 4 months 20. Need for forbidden medications 21. Breastfeeding 22. Consumption of iron-rich foods or any food that alter iron absorption (i.e. food rich in vitamin C) due to dietary requirements 23. 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)
Contact & Investigator
Gabriele Masini, MD PhD
PRINCIPAL INVESTIGATOR
University of Pisa
Frequently Asked Questions
Who can join the NCT06270498 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06270498 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06270498 currently recruiting?
Yes, NCT06270498 is actively recruiting participants. Contact the research team at gabriele.masini@unipi.it for enrollment information.
Where is the NCT06270498 trial being conducted?
This trial is being conducted at Pisa, Italy.
Who is sponsoring the NCT06270498 clinical trial?
NCT06270498 is sponsored by Raffaele De Caterina. The principal investigator is Gabriele Masini, MD PhD at University of Pisa. The trial plans to enroll 60 participants.
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