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

• ClinicalTrials.gov Identifier: NCT01394562
• Recruitment Status: Completed
• First Posted: July 14, 2011
• Last Update Posted: May 18, 2017
• Sponsor: Vifor (International) Inc.
• Information provided by (Responsible Party): Vifor (International) Inc.

Tracking Information

• First Submitted Date: July 12, 2011
• First Posted Date: July 14, 2011
• Last Update Posted Date: May 18, 2017
• Study Start Date: July 2011
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 12, 2011): Change in Peak VO2 (mL/kg/min) from baseline to Week 24 [ Time Frame: Week 24 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Iron Deficiency
• Chronic Heart Failure

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2015): 174
• Original Estimated Enrollment (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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT01394562
• Other Study ID Numbers: 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 (International) Inc.
• Study Sponsor: Vifor (International) Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dirk van Veldhuisen, MD; University Medical Center Groningen

• PRS Account: Vifor (International) Inc.
• Verification Date: December 2015