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Evaluation of Comprehensive iron therapy using hypoxia-inducible factor stabilizer in Patients with Heart Failure: Iron Deficiency pilot trial

Evaluation of Comprehensive iron therapy using hypoxia-inducible factor stabilizer in Patients with Heart Failure: Iron Deficiency pilot trial - IronHIFs-HF: ID Pilot Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051230146
Enrollment
50
Registered
2023-12-15
Start date
2024-09-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure patients with concomitant iron failure

Interventions

Comprehensive iron therapy group: iron therapy with sodium ferrous citrate/daprodustat for iron deficiency. Conservative treatment group: only observation of iron kinetics and no treatment for iron de

Sponsors

Toyota Toshiaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) hospitalized for heart failure 2) Iron deficiency (ferritin 13 g/dL and 12 g/dL and <15 g/dL 4) 18 years of age or older 5) Written consent has been obtained from the patient

Exclusion criteria

Exclusion criteria: 1) Active bleeding disorders 2) Hematopoietic tumor 3) Transfusion within 90 days prior to enrollment 4) Planned non-pharmacologic treatment for heart failure 5) Catecholamine-dependent status (via intravenous administration) 6) Pregnant women, women who wish to become pregnant during participation in the study, and breastfeeding mothers 7) Inappropriate to participate in this study by the attending physician or principal/participating investigator (e.g., life expectancy of less than 1 year)

Design outcomes

Primary

MeasureTime frame
Change in Short Physical Performance Battery (SPPB) total score at 3 months

Secondary

MeasureTime frame
-Change in SBBP total score, 6-minute walk distance, peak VO2, and NYHA -Change in hemoglobin level and NT-proBNP -Change in Left ventricular ejection fraction and Global Longitudinal Strain on transthoracic echocardiogram -All-cause mortality (cardiac death, sudden cardiac death, cardiovascular death, non-cardiac death, death at discharge) -Readmissions for heart failure (excluding laboratory admissions) and cardiac-related death (cardiac death, sudden cardiac death, cardiovascular death) -Cerebrovascular events (myocardial infarction, acute coronary syndrome, stroke [cerebral infarction, cerebral hemorrhage]) and cardiac death (cardiac death, sudden cardiac death, cardiovascular death) -Readmissions for heart failure (excluding laboratory admissions) -Non-pharmacologic treatment of unplanned heart failure -Implementation of standard treatment for heart failure (outpatient cardiac rehabilitation, optimal drug therapy) -Hemorrhagic complications (GUSTO classification, BARC classification) -Anemia -Malignant tumor -Dialysis -Adverse events

Contacts

Public ContactToshiaki Toyota

Kobe City Medical Center General Hospital

toyota@kcho.jp+81-78-302-4321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026