Phase IV, open-label, randomized clinical trial on the effect of intravenous iron on quality of life in elderly patients with Acute Coronary Syndrome.

Conditions

Acute coronary syndrome

Brief summary

Change in EQ-5D-5L score at 6 and 12 months vs. baseline (IV iron group vs. control).

Detailed description

Change in FRAIL Scale score at 6 and 12 months vs. baseline., Change in CRP and hs-CRP levels from baseline to 12 months., Incidence of decompensated heart failure requiring hospitalization (12 months)., Incidence of non-fatal myocardial infarction (1 year)., Incidence of stroke (1 year)., All-cause mortality at 12 months., Change in iron metabolism markers (iron, ferritin, serum ferritin, sTfR, TSAT, HIF-1, hepcidin) from baseline to 12 months (subgroup)., Change in inflammatory markers (CRP, hs-CRP, IL-1, IL-6, IL-10, IL-18, TNF-α) from baseline to 12 months (subgroup)., Change in biological age markers from baseline to 12 months (subgroup)., Change in telomere length from baseline to 12 months (subgroup)., Correlation of baseline Klotho and FGF23 values with adverse clinical events (HF decompensation, reinfarction, stroke, all-cause mortality) at 12 months (subgroup).

Related papers

No related papers found yet.

Interventions

DRUGFerinject 50 mg/ml dispersión inyectable y para perfusión

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in EQ-5D-5L score at 6 and 12 months vs. baseline (IV iron group vs. control).	—

Secondary

Measure	Time frame
Change in FRAIL Scale score at 6 and 12 months vs. baseline., Change in CRP and hs-CRP levels from baseline to 12 months., Incidence of decompensated heart failure requiring hospitalization (12 months)., Incidence of non-fatal myocardial infarction (1 year)., Incidence of stroke (1 year)., All-cause mortality at 12 months., Change in iron metabolism markers (iron, ferritin, serum ferritin, sTfR, TSAT, HIF-1, hepcidin) from baseline to 12 months (subgroup)., Change in inflammatory markers (CRP, hs-CRP, IL-1, IL-6, IL-10, IL-18, TNF-α) from baseline to 12 months (subgroup)., Change in biological age markers from baseline to 12 months (subgroup)., Change in telomere length from baseline to 12 months (subgroup)., Correlation of baseline Klotho and FGF23 values with adverse clinical events (HF decompensation, reinfarction, stroke, all-cause mortality) at 12 months (subgroup).	—

Measure

Time frame

Change in FRAIL Scale score at 6 and 12 months vs. baseline., Change in CRP and hs-CRP levels from baseline to 12 months., Incidence of decompensated heart failure requiring hospitalization (12 months)., Incidence of non-fatal myocardial infarction (1 year)., Incidence of stroke (1 year)., All-cause mortality at 12 months., Change in iron metabolism markers (iron, ferritin, serum ferritin, sTfR, TSAT, HIF-1, hepcidin) from baseline to 12 months (subgroup)., Change in inflammatory markers (CRP, hs-CRP, IL-1, IL-6, IL-10, IL-18, TNF-α) from baseline to 12 months (subgroup)., Change in biological age markers from baseline to 12 months (subgroup)., Change in telomere length from baseline to 12 months (subgroup)., Correlation of baseline Klotho and FGF23 values with adverse clinical events (HF decompensation, reinfarction, stroke, all-cause mortality) at 12 months (subgroup).

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Countries

Spain

Outcome results

None listed