Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity… (NCT03036462) | Clinical Trial Compass
CompletedPhase 4
Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality
Germany1,105 participantsStarted 2017-03-07
Plain-language summary
The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) extends the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death and reduces hospitalisation and mortality in patients with iron deficiency and heart failure.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with chronic HFrEF (CHF) of at least 3 months duration and a history of documented LVEF\<45%.
✓. Confirmed presence of ID (ferritin \< 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT \< 20 %)
✓. Serum haemoglobin of 9.5 - 14.0 g/dL
✓. At time of screening considered re-stabilised and planned for discharge within next 24 h (NYHA 2 or 3), or stable ambulatory with a HF hospitalisation in the past 12 months (NYHA 2-4), or stable ambulatory with BNP \> 100 pg/mL or NT-proBNP \> 300 pg/mL or MR-proANP \> 120 pmol/L (NYHA 2-4)
✓. Written informed consent
Exclusion criteria
✕. Hypersensitivity to the active substance, to FCM or any of its excipients
✕. Known serious hypersensitivity to other parenteral iron products
✕. Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia
✕. Evidence of iron overload or disturbances in the utilisation of iron
✕. History of severe asthma with known FEV1 \<50%
✕. Acute bacterial infection
✕. Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs to be corrected first)
✕
What they're measuring
1
Time-to-first event of CV death or HF hospitalisation
Timeframe: The whole follow-up period. We aim for a minimum average follow-up of >2 years. We aim for a minimum follow-up of 6 months for all patients, but not less than 3 months.
2
Rate of total (first and recurrent) events of hospitalisations for heart failure (HF)
Timeframe: The wohle follow-up period. We aim for a minimum average follow-up of >2 years. We aim for a minimum follow-up of 6 months for all patients, but not less than 3 months.
3
Time-to-first event of CV death or HF hospitalisation in patients with TSAT <20%
Timeframe: During the wohle follow-up period. We aim for a minimum average follow-up of >2 years. We aim for a minimum follow-up of 6 months for all patients, but not less than 3 months.