Iron Deficiency in cardiac surgery

Phase 1

• Conditions: Iron deficiency in cardiac surgery; MedDRA version: 20.0Level: LLTClassification code 10067709Term: HypoferrismSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001823-26-IT
• Lead Sponsor: IVERSITÀ CAMPUS BIO-MEDICO DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

LVEF = 40%
• Ferritin < 100 ng/mL
or between 100-300
ng/mL with TSAT <
20%
• Hb < 15 g/dl
age >18 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Subject with sensitivity to intravenous iron
2. History of acquired iron overload
3. Known active bacterial infection
4. Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or
aspartate transaminase above three times the upper
limit of the normal rang
5. WOCBP
6. Hypersensitivity to any of its excipients listed in IMP (section 6.1)
5. Clinical evidence of current malignancy
6. Currently receiving systemic chemotherapy and/or radiotherapy
7. Renal dialysis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Improvement of cardiac function;Secondary Objective: -LVEF, LV,diameters,<br>LAVI, LVMI, E/e¿<br>- Change in exercise<br>capacity(METs)<br>- Lenght of stay (LOS)<br>- Blood trasfusion;Primary end point(s): Change in Echo PSSR;Timepoint(s) of evaluation of this end point: 25 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Echo GLS<br>¿ LVEF, LV<br>diameters,<br>LAVI, LVMI, E/<br>e¿<br>¿ Change in<br>exercise<br>capacity(METs)<br>¿ Lenght of stay<br>(LOS)<br>¿ Blood<br>trasfusion;Timepoint(s) of evaluation of this end point: 25 weeks