Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure
EFFECT-HF
Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients With Iron Deficiency
2 other identifiers
interventional
174
1 country
1
Brief Summary
The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2011
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 18, 2017
December 1, 2015
4.8 years
July 12, 2011
May 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Peak VO2 (mL/kg/min) from baseline to Week 24
Week 24
Study Arms (2)
Ferinject (ferric carboxymaltose)
EXPERIMENTALStandard of Care
OTHERStandard of care. IV iron is not permitted
Interventions
Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12
Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron
Eligibility Criteria
You may qualify if:
- Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
- Reduced exercise capacity
- Reduced left ventricular ejection fraction
- At least 18 years of age and with written informed consent prior to any study specific procedures
You may not qualify if:
- Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation
- Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
- Chronic liver disease and/or elevated liver enzymes
- Vitamin B12 and/or serum folate deficiency
- Subject is not using adequate contraceptive precautions during the study
- No other significant cardiac or general disorder that would compromise participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vifor Pharmalead
Study Sites (1)
University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Related Publications (1)
van Veldhuisen DJ, Ponikowski P, van der Meer P, Metra M, Bohm M, Doletsky A, Voors AA, Macdougall IC, Anker SD, Roubert B, Zakin L, Cohen-Solal A; EFFECT-HF Investigators. Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Chronic Heart Failure and Iron Deficiency. Circulation. 2017 Oct 10;136(15):1374-1383. doi: 10.1161/CIRCULATIONAHA.117.027497. Epub 2017 Jul 12.
PMID: 28701470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk van Veldhuisen, MD
University Medical Center Groningen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 14, 2011
Study Start
July 1, 2011
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 18, 2017
Record last verified: 2015-12