Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart F⊠(NCT06270498) | Clinical Trial Compass
RecruitingPhase 4
Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure
Italy60 participantsStarted 2024-03-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
â. 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
â. LVEF\<50% at screening visit (historical value can be used if performed within 6 months of screening visit)
â. Either a documented hospitalization for HF in the previous 12 months of enrolment or an elevated NT-proBNP: â„250 pg/mL (or BNP â„75 pg/mL) for patients in normal sinus rhythm; â„1,000 pg/mL (or BNP â„400 pg/mL) for patients in atrial fibrillation
â. TSAT \<20%
â. Hemoglobin 10.0-16.0 g/dL
â. 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)
â. Age â„18 years, male and female
â. Willingness to provide informed consent
Exclusion criteria
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What they're measuring
1
Difference in six-minute walk test (6MWT) distance, expressed as meters
Timeframe: 12 weeks
2
Difference in Kansan City Cardiomyopathy Questionnaire (KCCQ)-12 overall score