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

NCT ID: NCT00834691

Last Updated: 2010-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31

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.

Conditions

Anemia; Heart Failure; Chronic Renal Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Patients with anemia and systolic heart failure

No interventions assigned to this group

2

Patients with systolic heart failure but without anemia

No interventions assigned to this group

3

Patients with at least moderate chronic renal failure, with or without anemia and without systolic heart failure.

No interventions assigned to this group

Eligibility 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Montreal Heart Institute

Locations

Montreal Heart Institute

Montreal, Quebec, Canada

Countries

Canada

References

O'Meara E, Clayton T, McEntegart MB, McMurray JJ, Lang CC, Roger SD, Young JB, Solomon SD, Granger CB, Ostergren J, Olofsson B, Michelson EL, Pocock S, Yusuf S, Swedberg K, Pfeffer MA; CHARM Committees and Investigators. Clinical correlates and consequences of anemia in a broad spectrum of patients with heart failure: results of the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) Program. Circulation. 2006 Feb 21;113(7):986-94. doi: 10.1161/CIRCULATIONAHA.105.582577. Epub 2006 Feb 13.

Reference Type: BACKGROUND

PMID: 16476847 (View on PubMed)

de Denus S, Tardif JC, White M, Bourassa MG, Racine N, Levesque S, Ducharme A. Temporal variations in hematocrit values in patients with left ventricular dysfunction: Relationship with cause-specific mortality and morbidity and optimal monitoring--further insights from SOLVD. Can J Cardiol. 2008 Jan;24(1):45-8. doi: 10.1016/s0828-282x(08)70547-6.

Reference Type: BACKGROUND

PMID: 18209768 (View on PubMed)

O'Meara E, Rouleau JL, White M, Roy K, Blondeau L, Ducharme A, Neagoe PE, Sirois MG, Lavoie J, Racine N, Liszkowski M, Madore F, Tardif JC, de Denus S; ANCHOR Investigators. Heart failure with anemia: novel findings on the roles of renal disease, interleukins, and specific left ventricular remodeling processes. Circ Heart Fail. 2014 Sep;7(5):773-81. doi: 10.1161/CIRCHEARTFAILURE.114.001100. Epub 2014 Jul 15.

Reference Type: DERIVED

PMID: 25027873 (View on PubMed)

Other Identifiers

07-938

Identifier Type: -

Identifier Source: org_study_id