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

Completed

• Conditions: Anemia; Heart Failure; Chronic Renal Failure

• Registration Number: NCT00834691
• Lead Sponsor: Montreal Heart Institute

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Primary Completion: 2010-02
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-30
• Last Update Posted: 2010-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TNF alpha concentrations	Visit 2 (within 2 weeks of baseline visit)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 MOntreal, Quebec, Canada