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

NCT06703411 | Completed Phase 4

• 1 other identifier: CHGH_IronSucrose_HFrEF_ID
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF); Hospitalization; Iron Deficiency

Keywords

Heart failure; Iron sucrose; Hospitalization; Quality of life

Outcome Measures

Primary Outcomes (1)

• KCCQ score (quality of life)

  KCCQ score (quality of life)

  4 weeks

Secondary Outcomes (1)

• Iron profiles

  4 weeks

Study Arms (2)

Iron sucrose

EXPERIMENTAL

IV iron sucrose 200mg per visit

Drug: Iron Sucrose IV; Drug: Standard Medical Therapy

Standard of care

ACTIVE COMPARATOR

Standard of care (HFrEF4 pillars treatment)

Drug: Standard Medical Therapy

Interventions

Iron Sucrose IV DRUG

IV iron sucrose 200mg per visit

Iron sucrose

Standard Medical Therapy DRUG

Standard of care (HFrEF 4 pillars treatment)

Iron sucrose; Standard of care

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead

Study Sites (1)

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Related Publications (2)

• Ponikowski P, Anker SD, AlHabib KF, Cowie MR, Force TL, Hu S, Jaarsma T, Krum H, Rastogi V, Rohde LE, Samal UC, Shimokawa H, Budi Siswanto B, Sliwa K, Filippatos G. Heart failure: preventing disease and death worldwide. ESC Heart Fail. 2014 Sep;1(1):4-25. doi: 10.1002/ehf2.12005.

  PMID: 28834669 BACKGROUND

• Sung HP, Yin WH, Chen SF, Hung CL, Lin KC, Chang HY. Intravenous Iron Sucrose for Acute Decompensated Heart Failure Patients with Reduced Ejection Fraction and Iron Deficiency. Rev Cardiovasc Med. 2025 Apr 17;26(4):28216. doi: 10.31083/RCM28216. eCollection 2025 Apr.

  PMID: 40351678 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Heart Failure

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: May 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)