Clinical trial NCT00834691: An Evaluation of the Causes of Anemia in Patients With Heart Failure
Official title: Anemia in Chronic Heart Failure: Etiology, Comparisons With Renal Disease, and Relationships With Biomarkers and Left Ventricular Remodeling.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Heart Failure
Chronic Renal Failure
Keywords: Inflammation
Oxidative stress
Estimated glomerular filtration rate
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2009-02-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


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

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

Primary outcomes:
measure: TNF alpha concentrations
timeFrame: Visit 2 (within 2 weeks of baseline visit)
Secondary outcomes:
measure: Various echocardiographic measurements, markers of inflammation, oxydative stress, neurohormonal activity and myocardial extracellular matrix turnover will be measured
timeFrame: Visit 2 (within 2 weeks of baseline visit)
Other outcomes:
Locations:
city: MOntreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
References:
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. doi: 10.1161/CIRCULATIONAHA.105.582577. Epub 2006 Feb 13.
citation: 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.
citation: 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.