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

JRCT ID: jRCTs051230146

Registered date:15/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure patients with concomitant iron failure
• Date of first enrollment: 15/12/2023
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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 deficiency.

Outcome(s)

• Primary Outcome: Change in Short Physical Performance Battery (SPPB) total score at 3 months

Secondary Outcome

-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
-Dialysis
-Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) hospitalized for heart failure
2) Iron deficiency (ferritin <100 ng/mL or transferrin saturation [TSAT] <20%)
3) Male: >13 g/dL and <15 g/dL; Female: >12 g/dL and <15 g/dL
4) 18 years of age or older
5) Written consent has been obtained from the patient

Exclude 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)

Related Information

• Primary Sponsor: Toyota Toshiaki
• Source(s) of Monetary Support: Actelion Pharmaceuticals Japan Ltd (Janssen Pharmaceutical K.K.)