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

NCT00386126 | Unknown Phase 2

• 1 other identifier: HCPA 06-115
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Anemia

Keywords

Heart Failure; Anemia; Treatment

Outcome Measures

Primary Outcomes (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 Outcomes (8)

• 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

Interventions

Iron Sucrose IV 200mg, once a week, for 5 weeks DRUG

Ferrous sulfate 200mg PO TID, for 8 weeks DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Cardiovascular Division, Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

Related Publications (1)

• Beck-da-Silva L, Piardi D, Soder S, Rohde LE, Pereira-Barretto AC, de Albuquerque D, Bocchi E, Vilas-Boas F, Moura LZ, Montera MW, Rassi S, Clausell N. IRON-HF study: a randomized trial to assess the effects of iron in heart failure patients with anemia. Int J Cardiol. 2013 Oct 9;168(4):3439-42. doi: 10.1016/j.ijcard.2013.04.181. Epub 2013 May 13.

  PMID: 23680589 DERIVED

MeSH Terms

Conditions

Heart Failure; Anemia

Interventions

WW Domain-Containing Oxidoreductase; ferrous sulfate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Nadine Clausell, MD

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Central Study Contacts

Luis Beck-da-Silva, MD

CONTACT

55 51 21018657; lbneto@hcpa.ufrgs.br

Michelle C Assis, RN

CONTACT

55 51 21018657; mcassis@hcpa.ufrgs.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: August 1, 2006
• Last Updated: October 11, 2006

Record last verified: 2006-08

Locations

BR (1)