EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure (EFFICACY-HF)

This study has been terminated.
(Positive FAIR-HF study data are available, this study is identical as EFFICACY-HF. Due to low recruitment in EFFICACY-HF the decision was made to terminate it.)
Sponsor:
Collaborator:
Socar Research SA
Information provided by:
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT00821717
First received: January 7, 2009
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.


Condition Intervention Phase
Chronic Heart Failure
Iron Deficiency
Iron Deficiency Anemia
Anaemia
Drug: Ferinject ® (Ferric carboxymaltose)
Drug: Normal saline (0.9%)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Controlled, Observer-blinded Phase III Clinical Trial to Compare the Effect of Intravenous Ferric Carboxymaltose to Placebo on Exercise Capacity and Cardiac Function in Patients With Chronic Heart Failure and Iron Deficiency

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks [ Time Frame: 24 weeks ]
  • NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Cardiac function assessed by 2D Echo/Doppler cardiography [ Time Frame: 24 weeks ]
  • Self-reported patient global assessment of treatment [ Time Frame: 24 weeks ]
  • QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi [ Time Frame: 24 weeks ]
  • Assesment at 4, 12 and 24 weeks [ Time Frame: 24 weeks ]

Estimated Enrollment: 330
Study Start Date: December 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Drug: Ferinject ® (Ferric carboxymaltose)

Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit.

After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase).

Placebo Comparator: 2 Drug: Normal saline (0.9%)
During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF)
  • Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III
  • Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations)
  • Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%

Exclusion Criteria:

  • History of acquired iron overload.
  • Known active infection, clinically significant bleeding, active malignancy.
  • Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST)
  • Anaemia due to reasons other than iron deficiency
  • Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
  • History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
  • Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
  • Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.
  • Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821717

  Show 41 Study Locations
Sponsors and Collaborators
Vifor Inc.
Socar Research SA
Investigators
Study Chair: Michael Motro, MD, FACC Sheba Medical Center, Tel-Hashomer 52621, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00821717     History of Changes
Other Study ID Numbers: FER-CARS-03
Study First Received: January 7, 2009
Last Updated: November 20, 2009
Health Authority: European Union: European Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
France: Direction Générale de la Santé
Israel: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Vifor Inc.:
Chronic Heart Failure
Iron deficiency
Iron deficiency anaemia
Anaemia
Heart disease

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Iron
Heart Failure
Heart Diseases
Cardiovascular Diseases
Hematologic Diseases
Metabolic Diseases
Malnutrition
Nutrition Disorders
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014