An Evaluation of the Causes of Anemia in Patients With Heart Failure

Study Overview
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Brief Summary
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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 concentrations of various substances related to inflammation, oxidative stress, renal function and other processes between individuals with 1) heart failure and anemia, 2) heart failure without anemia and 3) patients with kidney disease without systolic heart failure. This study will help to better understand the reasons why some people with heart failure have anemia.

Official Title
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Anemia in Chronic Heart Failure: Etiology, Comparisons With Renal Disease, and Relationships With Biomarkers and Left Ventricular Remodeling.

Conditions
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Anemia, Heart Failure, Chronic Renal Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with anemia and systolic heart failure | |
| 2<br>Patients with systolic heart failure but without anemia | |
| 3<br>Patients with at least moderate chronic renal failure, with or without anemia and without systolic heart failure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF alpha concentrations |  | Visit 2 (within 2 weeks of baseline visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various echocardiographic measurements, markers of inflammation, oxydative stress, neurohormonal activity and myocardial extracellular matrix turnover will be measured |  | Visit 2 (within 2 weeks of baseline visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Oxidative stress, Estimated glomerular filtration rate