Status:
UNKNOWN
Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Heart Failure
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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%. Mo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00386126
Start Date
August 1 2006
Last Update
October 11 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiovascular Division, Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003