Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure (EFFECT-HF)

Tracking Information
First Submitted Date ICMJE	July 12, 2011
First Posted Date ICMJE	July 14, 2011
Last Update Posted Date	May 18, 2017
Study Start Date ICMJE	July 2011
Actual Primary Completion Date	May 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 12, 2011)	Change in Peak VO2 (mL/kg/min) from baseline to Week 24 [ Time Frame: Week 24 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01394562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure
Official Title ICMJE	Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients With Iron Deficiency
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Iron Deficiency; Chronic Heart Failure
Intervention ICMJE	Drug: Ferinject (ferric carboxymaltose) Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12; Other: Standard of Care Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron
Study Arms	Experimental: Ferinject (ferric carboxymaltose) Intervention: Drug: Ferinject (ferric carboxymaltose); Standard of Care Standard of care. IV iron is not permitted Intervention: Other: Standard of Care
Publications *	van Veldhuisen DJ, Ponikowski P, van der Meer P, Metra M, Böhm 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 7, 2015)	174
Original Estimated Enrollment ICMJE; (submitted: July 12, 2011)	160
Actual Study Completion Date	May 2016
Actual Primary Completion Date	May 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Netherlands
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01394562
Other Study ID Numbers ICMJE	FER-CARS-04; 2011-000603-40 ( EudraCT Number )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Vifor Inc.
Study Sponsor ICMJE	Vifor Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Dirk van Veldhuisen, MD University Medical Center Groningen
PRS Account	Vifor Inc.
Verification Date	December 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP