Health Trials

About this trial

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

Qualifiers

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

LVEF<50% at screening visit (historical value can be used if performed within 6 months of screening visit)

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

TSAT <20%

Disqualifiers

Neuromuscular, orthopedic or other non-cardiac condition that prevents the patient from exercise testing

Exercise training program in the previous 3 months, or planned in the next 3 months

Recent (<3 month) acute coronary syndrome, coronary artery bypass surgery, percutaneous coronary interventions, transient ischemic attack, or stroke

Severe valvular disease, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, acute myocarditis

Trial design

Treatments tested in this trial

  • Sucrosomial iron
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

1
Azienda Ospedaliero Universitaria Pisana56124, PisaTuscany, Italy

Sponsors and collaborators

Raffaele De Caterina

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Sponsor institution

University of Pisa

Collaborator

Source ClinicalTrials.gov