EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure (EFFICACY-HF)
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|ClinicalTrials.gov Identifier: NCT00821717|
Recruitment Status : Terminated (Positive FAIR-HF study data are available, this study is identical as EFFICACY-HF. Due to low recruitment in EFFICACY-HF the decision was made to terminate it.)
First Posted : January 13, 2009
Last Update Posted : June 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure Iron Deficiency Iron Deficiency Anemia Anaemia||Drug: Ferinject ® (Ferric carboxymaltose) Drug: Normal saline (0.9%)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Controlled, Observer-blinded Phase III Clinical Trial to Compare the Effect of Intravenous Ferric Carboxymaltose to Placebo on Exercise Capacity and Cardiac Function in Patients With Chronic Heart Failure and Iron Deficiency|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||January 2011|
Drug: Ferinject ® (Ferric carboxymaltose)
Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit.
After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase).
|Placebo Comparator: 2||
Drug: Normal saline (0.9%)
During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.
- The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks [ Time Frame: 24 weeks ]
- NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment [ Time Frame: 24 weeks ]
- Cardiac function assessed by 2D Echo/Doppler cardiography [ Time Frame: 24 weeks ]
- Self-reported patient global assessment of treatment [ Time Frame: 24 weeks ]
- QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821717
Show 41 Study Locations
|Study Chair:||Michael Motro, MD, FACC||Sheba Medical Center, Tel-Hashomer 52621, Israel|