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

Primary Purpose

Iron Deficiency, Chronic Heart Failure

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

Ferinject (ferric carboxymaltose)

Standard of Care

About this trial

This is an interventional treatment trial for Iron Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ferinject (ferric carboxymaltose)

Standard of Care

Arm Description

Standard of care. IV iron is not permitted

Outcomes

Primary Outcome Measures

Change in Peak VO2 (mL/kg/min) from baseline to Week 24

Secondary Outcome Measures

Full Information

NCT ID

NCT01394562

First Posted

July 12, 2011

Last Updated

May 16, 2017

Sponsor

Vifor Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01394562

Brief Title

Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure

Acronym

EFFECT-HF

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vifor Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency, Chronic Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ferinject (ferric carboxymaltose)

Arm Type

Experimental

Arm Title

Standard of Care

Arm Type

Other

Arm Description

Standard of care. IV iron is not permitted

Intervention Type

Drug

Intervention Name(s)

Ferinject (ferric carboxymaltose)

Intervention Description

Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron

Primary Outcome Measure Information:

Title

Change in Peak VO2 (mL/kg/min) from baseline to Week 24

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dirk van Veldhuisen, MD

Organizational Affiliation

University Medical Center Groningen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Groningen

City

Groningen

ZIP/Postal Code

9700 RB

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

28701470

Citation

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.

Results Reference

derived

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Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure

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