NCT00834691已完成不适用
Anemia in Chronic Heart Failure: Etiology, Comparisons With Renal Disease, and Relationships With Biomarkers and Left Ventricular Remodeling.
Montreal Heart Institute1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2008年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- TNF alpha concentrations
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
TNF alpha concentrations
时间窗: Visit 2 (within 2 weeks of baseline visit)
次要结局
- 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))
研究者
研究点 (1)
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