Effect of intravenous iron on quality of life in older adults with acute coronary syndrome: a phase IV clinical study
Key facts
- Where
- Badajoz, Barcelona, Granada, León, Madrid, Murcia, Pamplona, Valencia és Vigo, SpanyolországSee the 9 sites
- Phase
- 4. fázis
Where in Spanyolország
- Hospital Universitario de BadajozBadajoz, SpanyolországTaking people
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Hospital Universitario Clínico San CecilioGranada, SpanyolországTaking people
- Hospital Universitario De LeonLeón, SpanyolországTaking people
- Hospital Clínico San CarlosMadrid, SpanyolországTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpanyolországTaking people
- Hospital Universitario de NavarraPamplona, SpanyolországTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpanyolországTaking people
- Hospital Alvaro CunqueiroVigo, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
- Trial code
- EU 2025-522421-36-00
- Record updated
- 2025. december 3.
- Original description
To determine whether patients aged 65 years or older, diagnosed with iron deficiency after an acute coronary syndrome (ACS), who receive intravenous iron treatment have a better quality of life at 6 and 12 months of follow-up compared to patients who do not receive treatment.Read full original descriptionShow less
Phase IV, open-label, randomized clinical trial on the effect of intravenous iron on quality of life in elderly patients with Acute Coronary Syndrome.
To determine whether patients aged 65 years or older, diagnosed with iron deficiency after an acute coronary syndrome (ACS), who receive intravenous iron treatment have a better quality of life at 6 and 12 months of follow-up compared to patients who do not receive treatment.
Inclusion: Patients aged 65 years or older; Patients with a confirmed diagnosis of acute coronary syndrome (ACS) within a maximum of 15 days prior to inclusion; Patients with a confirmed diagnosis of iron deficiency at the time of hospital admission or within 15 days after the cardiac event, untreated, and defined by: - Serum ferritin <100 ng/mL, or - Transferrin saturation (TSAT) <20%, according to the European Society of Cardiology guidelines and the SEC_SEMI consensus; Ability to understand the study details and to provide written informed consent prior to any trial-related procedures.
Exclusion: Patients with previously diagnosed iron deficiency, identified and treated with intravenous or oral iron within the year prior to the event; Patients with active cancer; Patients undergoing dialysis, or with advanced hepatic or renal failure; Patients with known hypersensitivity to intravenous iron or to any of the excipients in the product; Patients with known severe hypersensitivity to other parenteral iron products; Evidence of iron overload or disorders in iron utilization; Patients with a prior diagnosis of heart failure (HF) with a left ventricular ejection fraction (LVEF) <40%, or who develop this condition during hospitalization or within 15 days following the acute coronary syndrome (ACS) event will be excluded; Patients with severe anemia (hemoglobin <10 g/dL) at the time of the event or within the subsequent 15 days; Patients with ongoing bacteremia; Patients currently participating in other clinical trials involving investigational medicinal products; Patients who, in the opinion of the investigator, should not participate in the study due to difficulties in complying with procedures, restrictions, or requirements; Terminally ill patients as determined by the IDC-Pal score (Instrument for Diagnosing Complexity in Palliative Care).