An Evaluation of the Causes of Anemia in Patients With Heart Failure (ANCHOR)

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT00834691
First received: January 30, 2009
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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.


Condition
Anemia
Heart Failure
Chronic Renal Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Anemia in Chronic Heart Failure: Etiology, Comparisons With Renal Disease, and Relationships With Biomarkers and Left Ventricular Remodeling.

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • TNF alpha concentrations [ Time Frame: Visit 2 (within 2 weeks of baseline visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma and serum samples for analysis of biomarkers.


Estimated Enrollment: 180
Study Start Date: January 2008
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with anemia and systolic heart failure
2
Patients with systolic heart failure but without anemia
3
Patients with at least moderate chronic renal failure, with or without anemia and without systolic heart failure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

One hundred and eighty (180) patients will be enrolled in three groups.

Group 1: This group will involve 80 patients with anemia (hemoglobin < 120g/L in women and < 130 g/L in) and systolic heart failure (LVEF < or = 40%; New York Heart Association -NYHA- functionnal class II-IV).

Group 2: This group will include 50 patients with systolic heart failure (LVEF < or = 40%; New York Heart Association -NYHA- functionnal class II-IV), but without anemia (hemoglobin > or = 120g/L in women and > or = 130 g/L in men).

Group 3 : 50 patients with at least moderate CRF (eGFR < 60ml/min/1,73m2), and LVEF > or = 50%, with or without anemia.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834691

Locations
Canada, Quebec
Montreal Heart Institute
MOntreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Johnson & Johnson
  More Information

Publications:
Responsible Party: Eileen O'Meara, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT00834691     History of Changes
Other Study ID Numbers: 07-938
Study First Received: January 30, 2009
Last Updated: July 30, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Montreal Heart Institute:
Inflammation
Oxidative stress
Estimated glomerular filtration rate

Additional relevant MeSH terms:
Heart Failure
Anemia
Renal Insufficiency
Kidney Failure, Chronic
Heart Diseases
Cardiovascular Diseases
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 22, 2014