Oral sucrosomial iron's effect on exercise and quality of life in heart failure patients

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

This study is testing if a new type of oral iron can help people with heart failure and low iron feel better and exercise more easily compared to a placebo.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda Ospedaliero, Universitaria Pisana (other)
• Locations: 1 site (Pisa, Tuscany)
• Trial ID: NCT06270498 on ClinicalTrials.gov

What this trial studies

This study investigates how oral sucrosomial iron affects exercise capacity and quality of life in patients suffering from chronic heart failure and iron deficiency. Participants will be divided into two groups, one receiving oral sucrosomial iron and the other a placebo. The primary outcomes will be measured through a six-minute walk test for exercise capacity and the Kansas City Cardiomyopathy Questionnaire for quality of life. The study aims to determine if this new oral iron formulation can improve symptoms compared to traditional treatments.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic heart failure, left ventricular ejection fraction less than 50%, and documented iron deficiency.

Not a fit: Patients who require immediate iron repletion through intravenous methods or those with severe anemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance exercise capacity and quality of life for patients with heart failure and iron deficiency.

How similar studies have performed: Previous studies have shown that intravenous iron can improve symptoms in similar patient populations, but the use of oral sucrosomial iron is a novel approach.

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 \&gt;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)

Where this trial is running

Pisa, Tuscany

• Azienda Ospedaliero Universitaria Pisana — Pisa, Tuscany, Italy (RECRUITING)

Study contacts

• Principal investigator: Gabriele Masini, MD PhD — University of Pisa
• Study coordinator: Gabriele Masini, MD PhD

Conditions: Chronic Heart Failure, Iron-deficiency, Left Ventricular Systolic Dysfunction, heart failure, iron deficiency, sucrosomial iron