The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration
研究概览
简要总结
- Study Hypothesis:
- The decrease of plasma adrenomedullin (ADM) concentration by ultrafiltration and isovolumetric hemofiltration in patients with acute III and IV Class New York Heart Association Functional(NYHA) heart failure is more pronounced than a standard diuretic treatment and is related with clinical improvement.
- Outcome Measurements:
To correlate the adrenomedullin plasma levels with clinical treatment, ultrafiltration and hemofiltration related to:
- Brain natriuretic peptide (BNP) level
- angiotensin II level
- sympathetic nervous activity
- oxydative stress
- clinical outcome at the beginning, at discharge and 90 days after randomization.
详细描述
Testing the hypothesis that adrenomedullin (ADM) is a important peptide in severe heart failure and that is related to clinical condition, we will study the effects of 3 different treatments (clinical usual treatment,ultrafiltration and isovolumetric hemofiltration with diuretics) to participants are followed until discharge to Adrenomedullin level and clinical outcomes,and also their relationship with angiotensin II level, brain natriuretic peptide(BNP), sympathetic nervous system and oxydative stress.
The patients will be randomized in three different treatment group and analyzed in three moments: on the randomization, at discharge and 90 days after randomization(plus or minus 3).
The clinical treatment will be optimized, the ultrafiltration will be done until clinically adequate fluid removal or until hematocrit increased 10% from basal level, and isovolumetric hemofiltration will be done for 8 hours- dose of 35 ml/kg/h in association with diuretic. All this dialytic procedures will be done with PAES membrane- filter HF1400 and automatic machine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •more than two item:
- •more than eighteen years of age
- •orthopnea
- •Chest Rx with cardiomegaly and pulmonary infiltration
- •diuretic resistance
排除标准
- •insulin dependent diabetes
- •hepatic cirrhosis
- •vascular access problems
- •creatinine more than 2,5 mg/dl before acute heart failure
- •systemic infection
- •aortic stenosis and heart transplantation
- •radiologic contrast up to 72 hours prior randomization
- •advanced neoplasia
研究组 & 干预措施
clinical treatment
Patients with previous diagnosis of decompensated III and IV Heart Failure will be included. The clinical treatment will be optimized.
Clinical assessment, Adrenomedullin, Angiotensin II, Brain Natriuretic Peptide, oxydative stress, sympathetic nervous system activity will be evaluated at the beginning, at discharge and 90 days after randomization(plus or minus3).
干预措施: clinical treatment (Other)
ultrafiltration
ultrafiltration will be done on decompensated patients III and IV acute heart failure on Intensive Care Unit. This patients will have biochemical analysis, adrenomedullin, angiotensin II,Brain Natriuretic Peptide, oxydative stress measurements,sympathetic nervous system activity evaluated and clinical outcome analyzed at the beginning,at discharge and 90 days after randomization(plus or minus 3).
Diuretic will be withdrawn during ultrafiltration.
干预措施: ultrafiltration (Procedure)
isovolumetric hemofiltration
Patients randomized to this group will have isovolumetric hemofiltration on Intensive Care Unit. They will have biochemical analysis, Adrenomedullin plasmatic level, Brain Natriuretic Peptide Level, Angiotensin II level, Oxydative stress measurement,sympathetic nervous system, and clinical outcome evaluated at the study beginning,at discharge and 90 days after randomization(plus or minus 3).
干预措施: isovolumetric hemofiltration (Procedure)
结局指标
主要结局
Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration
时间窗: at discharge
The adrenomedullin level will be compared in three different treatments: clinical treatment, ultrafiltration treatment and isovolumetric hemofiltration. The patients will be followed until discharge.
Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration
时间窗: 90 days after randomization (plus or minus 3 days).
The adrenomedullin level will be compared in three different treatments: clinical treatment, ultrafiltration treatment and isovolumetric hemofiltration.
次要结局
- The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.(90 days after randomization (plus or minus 3))
- The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress(90 days after randomization(plus or minus 3))
- The Adrenomedullin plasma levels in three different treatment approaches will be related to angiotensin II plasma level(90 days after randomization(plus or minus 3))
- The Adrenomedullin plasma levels in three different treatment approaches will be related to Brain natriuretic peptide plasma level(at discharge)
- The Adrenomedullin plasma levels in three different treatment approaches will be related to Pro-Brain natriuretic peptide plasma level(90 days after randomization(plus or minus 3))
- The Adrenomedullin plasma levels in three different treatment approaches will be related to sympathetic nervous system activity(90 days after randomization(plus or minus 3))
- The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.(at discharge)
- The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress(at discharge)
- The Adrenomedullin plasma levels in three different treatment approaches will be related to angiotensin II plasma level(at discharge)
- The Adrenomedullin plasma levels in three different treatment approaches will be related to sympathetic nervous system activity(at discharge)
研究者
Anna Stein
MD
Federal University of São Paulo