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

Heart Failure Clinical Trial

— ANCHOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834691
• Other study ID #: 07-938
• Status: Completed
• Phase: N/A
• First received: January 30, 2009
• Last updated: July 30, 2010
• Start date: January 2008

Study information

• Verified date: July 2010
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anemia
• Chronic Renal Failure
• Heart Failure
• Kidney Failure, Chronic

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	MOntreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Johnson & Johnson

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. Epub 2006 Feb 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNF alpha concentrations		Visit 2 (within 2 weeks of baseline visit)	No
Secondary	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)	No