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Completed

NCT Number: NCT00834691

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. TNF alpha concentrations

    Time frame: Visit 2 (within 2 weeks of baseline visit)

Secondary outcomes

  1. Various echocardiographic measurements, markers of inflammation, oxydative stress, neurohormonal activity and myocardial extracellular matrix turnover will be measured

    Time frame: Visit 2 (within 2 weeks of baseline visit)

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Acronym: ANCHOR

Important dates

Study start
2008
Primary completion
2010
First posted
Feb 3, 2009
Registry last updated
Aug 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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