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

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: 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. CONDITION: Heart failure patients with concomitant iron failure 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 INCLUSION 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
Epistemonikos ID: f4429535353f17a0bfb5b40babb46ef549077b44
First added on: Aug 28, 2024