Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRaffaele De Caterina
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sucrosomial iron
Dietary supplementSucrosomial iron with the addition at a fixed dose of vitamin C to promote iron absorption (SiderAL® Forte) will be administered orally once a day for 24 weeks. The dose regimen for all participants will be calculated according to the haemoglobin (Hb) levels at baseline evaluation and to patient's body weight as follows: Hb 14-16 g/dL: 1 tablet once a day, corresponding to 30 mg/daily, for 24 weeks; Hb 10-13.9 g/dL: 2 tablets once a day, corresponding to 60 mg/daily, for 24 weeks
Placebo
Other interventionPlacebo pills will be identical in shape, form and color of SI tablets; they will contain the same components of SiderAL Forte® except for sucrosomial iron and vitamin C. Placebo will be administered orally once a day for 3 months according to the same dose scheme in the intervention arm.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sucrosomial ironActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in six-minute walk test (6MWT) distance, expressed as meters
Time frame
12 weeks2
Difference in Kansan City Cardiomyopathy Questionnaire (KCCQ)-12 overall score
Time frame
12 weeksSecondary outcomes
1
Proportion of patients with 15 meters improvement in 6MWT distance (responders)
Time frame
12 weeks2
Proportion of patients with 5-point improvement in KCCQ-12 score (responders)
Time frame
12 weeks3
Difference in six-minute walk test (6MWT) distance, expressed as meters
Time frame
24 weeks4
Difference in Kansan City Cardiomyopathy Questionnaire (KCCQ)-12 overall score
Time frame
24 weeksOther outcomes
1
Adverse events and allergic reactions
Number of any adverse events and number of allergic reactions
Time frame
12 weeks2
Adverse events and allergic reactions
Number of any adverse events and number of allergic reactions
Time frame
24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Raffaele De Caterina
Lead sponsor
Azienda Ospedaliero, Universitaria Pisana
Sponsor institution
University of Pisa
Collaborator
Source ClinicalTrials.gov