Clinical Trial: Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality - FAIR-HF2

Brief Summary: The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron deficiency and heart failure.

Detailed Summary:

The clinical trial is designed as an international, prospective, multi-centre, double-blind, parallel group, randomised, controlled, interventional trial to investigate whether a long-term therapy with i.v. iron (ferric carboxymaltosis) compared to placebo can reduce the rate of recurrent heart failure hospitalisations and cardiovascular (CV) death in patients with heart failure with reduced ejection fraction (HFrEF).

I.v. iron administration in the form of ferric carboxymaltosis (FCM) will be carried out according to the Summary of Product Characteristics (SmPC). Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg FCM at every 4 months, except when haemoglobin is > 16.0 g/dL or ferritin is > 800 µg/L.

In the verum group, all patients will receive a saline administration, when no iron is indicated at the time of the visit and according to the values listed above. Patients originally assigned to the placebo group will receive a saline administration at all visits.

In the control group i.v. NaCl at a volume according to the dosing rules for FCM at all visits will be administered in a double-blind manner.


Sponsor: Universitätsklinikum Hamburg-Eppendorf

Current Primary Outcome: Combined rate of recurrent hospitalisations for heart failure (HF) and of cardiovascular death (number of events) [ Time Frame: at least after 12 month of follow-up ]

Combined rate of recurrent hospitalisations for heart failure and of cardiovascular death during follow-up.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death (number of events) [ Time Frame: at least after 12 month of follow-up ]
    Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death during follow-up
  • Combined rate of recurrent hospitalisations for any reason and of cardiovascular death (number of events) [ Time Frame: at least after 12 month of follow-up ]
    Combined rate of recurrent hospitalisations for any reason and of cardiovascular death during follow-up
  • Rate of recurrent cardiovascular hospitalisations (number of events) [ Time Frame: at least after 12 month of follow-up ]
    Rate of recurrent cardiovascular hospitalisations during follow-up
  • Rate of recurrent HF hospitalisations (number of events) [ Time Frame: at least after 12 month of follow-up ]
    Rate of recurrent HF hospitalisations during follow-up
  • Rate of recurrent hospitalisations of any kind (number of events) [ Time Frame: at least after 12 month of follow-up ]
    Rate of recurrent hospitalisations of any kind during follow-up
  • All-cause mortality (number of events) [ Time Frame: at least after 12 month of follow-up ]
    All-cause mortality during follow-up
  • cardiovascular mortality (number of events) [ Time Frame: at least after 12 month of follow-up ]
    cardiovascular mortality during follow-up
  • Changes in NYHA (New York Heart Association) functional class (scale) [ Time Frame: at least after 12 month of follow-up ]
    Changes in NYHA functional class during follow-up
  • Changes in 6-minute walk-test (nomogram) [ Time Frame: at least after 12 month of follow-up ]
    Changes in 6-minute walk-test during follow-up
  • Changes in EQ-5D (questionnaire) [ Time Frame: at least after 12 month of follow-up ]
    Changes EQ-5D during follow-up
  • Changes in Patient Global Assessment (PGA) of wellbeing (questionnaire) [ Time Frame: at least after 12 month of follow-up ]
    Changes in PGA of wellbeing during follow-up
  • Changes in renal parameters (laboratory parameters) [ Time Frame: at least after 12 month of follow-up ]
    Changes in renal from baseline to end of follow-up
  • Changes in cardiovascular parameters (laboratory parameters) [ Time Frame: at least after 12 month of follow-up ]
    Changes in cardiovascular parameters from baseline to end of follow-up
  • Changes in inflammatory parameters (laboratory parameters) [ Time Frame: at least after 12 month of follow-up ]
    Changes in inflammatory parameters from baseline to end of follow-up
  • Changes in metabolic parameters (laboratory parameters) [ Time Frame: at least after 12 month of follow-up ]
    Changes in metabolic parameters from baseline to end of follow-up


Original Secondary Outcome: Same as current

Information By: Universitätsklinikum Hamburg-Eppendorf

Dates:
Date Received: September 15, 2016
Date Started: February 7, 2017
Date Completion: October 2020
Last Updated: March 21, 2017
Last Verified: March 2017