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OpenTrials
Completed

NCT Number: NCT01394562

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

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.

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Key information

Conditions

Iron Deficiency Chronic Heart Failure Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferinject (ferric carboxymaltose)

Drug

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

Standard of care

Other

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 outcomes

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

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Vifor Pharma

Industry

Registry information

Official study 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

Acronym: EFFECT-HF

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2011
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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