Heart Failure Clinical Trial
Official title:
Hospitalization and Mortality in Iron Deficient, Anemic Patients With Chronic Kidney (CKD) and Heart Failure Receiving Intravenous Iron Therapy: A Five Year Follow-up From a Pilot Study
Verified date | March 2015 |
Source | Hospital Aleman |
Contact | n/a |
Is FDA regulated | No |
Health authority | Argentina: Ministry of Health |
Study type | Interventional |
Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well as impairing health-related quality of life in chronic heart failure (CHF), and these effects are compounded when patients also experience chronic kidney disease (CKD). This study was designed to determine the effects of intravenous iron treatment on morbidity and mortality following an initial 6-month period and a longer period of up to 5 years.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion: - LV ejection fraction (EF) = 35% - New York Heart Association (NYHA) functional class II to IV - Anemia with an iron deficit defined by Hb 12.5 g/dl for men and 11.5 g/dl for women, and some of the following: serum ferritin 100 ng/ml and/or with transferrin saturation (TSAT) 20% - Creatinine clearance 90 ml/min. Exclusion: - Hemodialysis therapy - Anemia not due to iron deficiency - NYHA functional class I - History of allergy to the iron supplements - Acute bacterial infections, parasitism known in the 4 previous weeks - Neoplasm - Chronic digestive diseases - Hypothyroidism - Congenital cardiopathies - Receiving iron supplements in the 4 previous weeks - Receiving rhEPO in the 4 previous weeks - History of hospitalization during the 4 weeks before enrollment into the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Aleman | Buenos Aires | Caba |
Lead Sponsor | Collaborator |
---|---|
Hospital Aleman |
Argentina,
Toblli JE, Lombraña A, Duarte P, Di Gennaro F. Intravenous iron reduces NT-pro-brain natriuretic peptide in anemic patients with chronic heart failure and renal insufficiency. J Am Coll Cardiol. 2007 Oct 23;50(17):1657-65. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mortality | 5 years | Yes | |
Secondary | Hospitalization | 5 years | Yes |
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