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

Launched by RAFFAELE DE CATERINA · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a new type of iron supplement called oral sucrosomial iron is for improving exercise ability and quality of life in patients with heart failure and low iron levels. The study will compare two groups: one group will take the iron supplement, while the other group will receive a placebo, which is a pill that looks like the medication but has no active ingredients. The main goals are to see if the iron supplement helps people walk further in six minutes and feel better overall, as measured by a specific questionnaire about heart health.

To participate, you need to be an adult aged 18 or older who has chronic heart failure and meets certain health criteria, such as having a specific level of heart function and iron deficiency. You should be stable on your heart medication for at least four weeks before joining. However, if you have certain health conditions or recent medical events, you may not be eligible. If you join the study, you'll be monitored closely, and your exercise capacity will be tested. This study is currently recruiting participants, and it’s a chance to contribute to research that could help improve treatments for heart failure.

Gender

ALL

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: \>300 pg/mL (or BNP \>100 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 10.0-15.0 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\>15 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)