Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00386126
Recruitment Status : Unknown
Verified August 2006 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : October 11, 2006
Last Update Posted : October 11, 2006
Information provided by:
Hospital de Clinicas de Porto Alegre

Brief Summary:
Anemia has been demonstrated to be a common finding in patients with heart failure (HF). Previous studies in hospitalized patients with HF have found a prevalence of anemia ranging from 15% to 63%. More importantly, anemic patients with HF have increased morbidity and mortality. The mechanisms underlying anemia in HF are multifactorial, involving mild to moderate forms of anemia of chronic disease and ferropenic anemia. The clinical impact of iron supplementation in HF patients who have a relatively preserved renal function and either chronic disease anemia, ferropenic anemia or both remains largely unknown. The route of iron administration that could be most clinically effective is also unclear. Thus, the primary aim of the IRON-HF study is to assess the effects of iron supplementation alone (IV or PO) on parameters of functional capacity in HF patients with anemia with decreased availability of iron.

Condition or disease Intervention/treatment Phase
Heart Failure Anemia Drug: Iron Sucrose IV 200mg, once a week, for 5 weeks Drug: Ferrous sulfate 200mg PO TID, for 8 weeks Phase 2 Phase 3

Detailed Description:

The IRON-HF study is an investigator initiated, multicenter, prospectively designed,randomized, double-blind, placebo controlled clinical trial.

Randomization:Each of the eight participating centers will randomize patients by telephone contact with the randomization center at Hospital de Clínicas de Porto Alegre. The randomization system will be based on a computerized table of random numbers and performed in blocks of three per participating center.

Blinding:Each participating center will elect a third party blind individual (usually a RN) who will open the allocated medication box, prepare iron sucrose infusions or saline and administer to patients in opaque devices. Both patient and attending physicians and/or nurses will be blind to allocated therapy. Oral medications and oral placebo will be identical in all aspects.

Study Type : Interventional  (Clinical Trial)
Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study
Study Start Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.

Secondary Outcome Measures :
  1. New York Heart Association (NYHA) functional class
  2. BNP (B-type natriuretic peptide) levels
  3. Quality of life using the Living with Heart Failure Minnesota Questionnaire
  4. Left ventricular ejection fraction (LVEF) as assessed by the bi-planar modified Simpson method in two-dimensional echocardiography
  5. Renal function as assessed by the serum levels of creatinine
  6. Incidence of hospitalizations due to HF
  7. Mortality
  8. Incidence of adverse events (drug tolerance).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older;
  • Outpatients followed at a HF Clinic in a tertiary care Hospital with clinical diagnosis of HF for at least 3 months before study entry;
  • NYHA functional class II to IV, who are able to perform ergospirometry;
  • Documentation of LVEF < 40% within the last 6 months;
  • Adequate baseline therapy for HF based on patient’s functional class (β-blockers, ACE inhibitors irrespective of functional class except if contra-indications, digoxin, spironolactone if NYHA class III or IV);
  • Stable baseline HF therapy with same doses of medications and no intent to increase doses for the following 3 months;
  • Hemoglobin ≤ 12 g/dl and > 9 g/dl;
  • Transferrin saturation < 20% and ferritin < 500 µg/L;
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Any clinically overt bleeding: gastrointestinal bleeding, hypermenorrhea, history of peptic ulcer without evidence of healing or inflammatory intestinal diseases;
  • Uncorrected hypothyroidism;
  • Other inflammatory, neoplastic or infectious disease;
  • Serum creatinine > 1,5 mg/dl;
  • Previous intolerance to oral elemental iron compounds;
  • HF due to alcoholic cardiomyopathy, current regular drinker of alcoholic beverages or HF due to peripartum cardiomyopathy;
  • Recent admission for decompensated HF (last month)
  • Recent myocardial revascularization procedures (last 3 months);
  • Recent ACS, stroke or TIA (last 3 months);
  • Active or metastatic neoplastic disease with life expectancy of less than a year;
  • Patients in heart transplantation list;
  • Patients that had participated in any other clinical trial or study within the last month;
  • Pregnant or lactating women;
  • Pre-menopausal women that are not using any effective method of contraception;
  • Patients using prohibited medications or that have not yet accomplished the wash-out period;
  • Patients currently participating in cardiovascular rehabilitation programs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00386126

Contact: Luis Beck-da-Silva, MD 55 51 21018657 ext 8657
Contact: Michelle C Assis, RN 55 51 21018657 ext 8657

Cardiovascular Division, Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Luis Beck-da-Silva, MD    55 5121018344 ext 8344   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Study Chair: Nadine Clausell, MD Hospital de Clínicas de Porto Alegre

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00386126     History of Changes
Other Study ID Numbers: HCPA 06-115
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: October 11, 2006
Last Verified: August 2006

Keywords provided by Hospital de Clinicas de Porto Alegre:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Hematologic Diseases
Ferric oxide, saccharated
Trace Elements
Growth Substances
Physiological Effects of Drugs