CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 76 enrolled
Drug / intervention
Iron Sucrose IV +1 moredrug
Likely dose
Iron Sucrose IV 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06703411
NCT06703411Phase 4Completed

Intravenous Iron Sucrose for Acute Decompensated Heart Failure Patients With Reduced Ejection Fraction and Iron Deficiency

Cheng-Hsin General Hospital·interventional·Posted Nov 25, 2024·Updated Nov 25, 2024

In Brief

A Phase 4 clinical trial evaluating Iron Sucrose IV and Standard Medical Therapy for Heart Failure With Reduced Ejection Fraction (HFrEF) and 2 related conditions. Completed, enrolled 76 participants across 1 site.

Detailed Summary

Iron deficiency (ID) affects about 25% of the global population, presenting with symptoms of fatigue, weakness, and impaired cognitive function. Its prevalence is lower in developed regions, due to fortified foods, supplements, and better healthcare. In contrast, ID is more common in resource-limited countries, where diets lack iron, healthcare is less accessible, and infections like malaria and hookworm are more prevalent. In Asia, ID rates vary widely, influenced by dietary habits, socioeconomic factors, and healthcare quality. The concurrent presence of ID and heart failure (HF) is increasingly acknowledged as a significant clinical issue, leading to a worsened prognosis and diminished quality of life for those affected. Recent research has reported a high prevalence of ID among HF patients, ranging from 30% to 50%, depending on the population studied and the diagnostic criteria used. Furthermore, ID in HF is linked with increased disease severity, higher hospitalization rates, and a greater risk of mortality. Interestingly, the prevalence of co-existing ID among HF patients does not vary between Western and Asian cohorts. Recent clinical trials involving the supplement of ferric carboxymaltose have shown the effectiveness of intravenous iron therapy in enhancing exercise capacity, improving quality of life, and reducing HF-related hospitalizations in patients with heart failure and reduced ejection fraction (HFrEF) and ID. The European and American guidelines both recommend routine screening for ID in HFrEF patients and suggest considering iron carboxymaltose for those with ID to improve clinical outcomes. Despite the importance of addressing ID in HF for optimizing patient care and improving prognosis, in many countries, due to the high price of iron carboxymaltose, only iron sucrose is available for intravenous iron supplementation, which is contrary to current guidelines. The efficacy and safety of intravenous iron sucrose in patients with HF and ID were demonstrated in the FERRIC-HF trial, but this study was conducted more than a decade ago. In an era marked by significant changes in HF treatment approaches, it remains unclear whether intravenous iron sucrose provides benefits to HF patients receiving current treatment. In this study, our objective is to examine the impact of intravenous iron sucrose on acutely decompensated HFrEF patients with co-existing ID, with a focus on improvements in iron profiles and quality of life. Our hypothesis suggests that, despite advancements in standard HF treatments, the additional use of intravenous iron sucrose could lead to an improved quality of life among HFrEF patients with ID.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedNov 25, 2024
Enrollment StartMay 1, 2023
Primary CompletionOct 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 1.6 years ago

Interventions

Iron Sucrose IVdrug

IV iron sucrose 200mg per visit

Standard Medical Therapydrug

Standard of care (HFrEF 4 pillars treatment)