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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00386126
First received: October 6, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

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

Estimated Enrollment: 117
Study Start Date: August 2006
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.

  Eligibility

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

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.
  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: NCT00386126

Contacts
Contact: Luis Beck-da-Silva, MD 55 51 21018657 ext 8657 lbneto@hcpa.ufrgs.br
Contact: Michelle C Assis, RN 55 51 21018657 ext 8657 mcassis@hcpa.ufrgs.br

Locations
Brazil
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    lbneto@hcpa.ufrgs.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Chair: Nadine Clausell, MD Hospital de Clínicas de Porto Alegre
  More Information

No publications provided by Hospital de Clinicas de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00386126     History of Changes
Other Study ID Numbers: HCPA 06-115
Study First Received: October 6, 2006
Last Updated: October 6, 2006
Health Authority: Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Anemia
Heart Failure
Hematologic Diseases
Heart Diseases
Cardiovascular Diseases
Ferric oxide, saccharated
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014