Status:
COMPLETED
An Evaluation of the Causes of Anemia in Patients With Heart Failure
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Anemia
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Anemia is frequent in patients with heart failure. Few studies have clearly addressed the causes of anemia in patients with HF. The purpose of this study is to evaluate differences in blood concentrat...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Groups 1 and 2
- Age \>18 years
- Group 1: hemoglobin \< 120g/L in women and \< 130 g/L in men (in agreement with the WHO definition of anemia)
- Group 2: hemoglobin \> or = 120g/L in women and \> or = 130 g/L in men
- Patients with chronic HF referred to a specialized HF clinic, or with a diagnosis of HF at least 6 months prior to enrolment
- NYHA functional class II-IV at the time of enrolment
- Patients already on CHF medical therapy (ACEI or ARBs, beta-blockers if tolerated, with or without digoxin, and loop diuretics), at stable doses for \> or = 1 month
- LVEF \< or = 40% within 6 months prior to patient enrolment, by echocardiography, radionuclide ventriculography or perfusion scan, or radiologic angiography
- Inclusion criteria - group 3
- Age \>18 years
- At least moderate CRF (eGFR \< 60ml/min/1,73m2)
- With or without anemia
- LVEF \> or = 50% within 6 months prior to patient enrolment, by echocardiography, radionuclide ventriculography or perfusion scan, or radiologic angiography
- Exclusion Criteria (all groups):
- Recent acute renal failure episode (\< 1 month)
- Red blood cells (or other blood component) transfusions or EPO therapy within 3 months prior to enrolment
- Iron, B12 or folic acid supplements used to treat anemia (\< 3 months)
- Evidence of active GI bleeding
- Recent acute coronary syndrome or decompensated HF episode (\< 1 month)
- Complex congenital heart disease
- Known malignant hematologic or other active neoplasia
- Immunosuppressive therapy, chemotherapy or radiotherapy within 3 months prior to enrolment
- Recent acute decompensation of a chronic inflammatory disease (e.g. chronic inflammatory bowel disease, rheumatoid arthritis, collagen vascular disease) within 3 months prior to enrolment
- Recent viral or bacterial syndrome (\< 2 weeks)
- Active or recent viral hepatitis (\< 3 months)
- Pregnant women
- Potential for non compliance to tests involved in this protocol
- Incapacity to provide informed consent
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00834691
Start Date
January 1 2008
Last Update
August 2 2010
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8