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Losartan in Decompensated Heart Failure

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InCor Heart Institute

关键词

抽象

The dual blockade of the renin-angiotensin-aldosterone system with an angiotensin-converting enzyme inhibitor and an angiotensin-receptor blocker used together in heart failure patients has been demonstrated to be beneficial. However, the dual inhibition has not been studied during heart failure decompensation or even when low cardiac output is present.
The objective of this study was to assess the effects of add-on therapy with angiotensin receptor blocker on plasma B-type natriuretic peptide levels and hemodynamic measurements in heart failure patients with low cardiac output during hospitalization for decompensation.
This was a randomized, double-blind, placebo-controlled clinical trial.

描述

The inclusion criteria were hospitalization for decompensated heart failure defined by worsening of symptoms until fatigue or dyspnea at rest, low cardiac output defined by the clinical-hemodynamic profile, dobutamine dependence, and ejection fraction < 0.45, spontaneous breathing and receiving angiotensin-converting enzyme inhibitors. The patients could have jugular ingurgitation, lower limbs edema, ascites and rales. Dobutamine dependence was defined by infusion for more than 15 days or an unsuccessful attempt of withdrawal.

The exclusion criteria were serum creatinine > 3.0 mg/dL, serum potassium > 6.0 mEq/L, systolic blood pressure < 70 mm Hg, aortic stenosis, and acute coronary syndrome in the previous 2 months. The patients were randomly assigned by permuted block of 4, stratified by sex, to losartan or placebo.

The endpoints were change in B-type natriuretic peptide levels, cardiac index, pulmonary wedge capillary pressure, systemic vascular resistance, and successful withdrawal of dobutamine.

日期

最后验证: 02/28/2011
首次提交: 05/15/2013
提交的预估入学人数: 05/16/2013
首次发布: 05/19/2013
上次提交的更新: 05/16/2013
最近更新发布: 05/19/2013
实际学习开始日期: 08/31/2008
预计主要完成日期: 01/31/2011
预计完成日期: 02/28/2011

状况或疾病

Congestive Heart Failure
Low Cardiac Output

干预/治疗

Drug: Losartan

Drug: Placebo

相 4

手臂组

干预/治疗
Experimental: Losartan
Losartan 50 mg bid orally
Drug: Losartan
Placebo Comparator: Placebo
Placebo 1 pill bid orally
Drug: Placebo

资格标准

有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- hospitalization for decompensated heart failure

- dobutamine dependence

- ejection fraction < 0.45

- taking angiotensin-converting enzyme inhibitor

Exclusion Criteria:

- serum creatinine > 3.0 mg/dL

- serum potassium > 6.0 mEq/L

- systolic blood pressure < 70 mm Hg

- aortic stenosis

- acute coronary syndrome in the previous 2 months

结果

主要结果指标

1. B-type natriuretic peptide [7 days]

Serum B-type natriuretic peptide

次要成果指标

1. Successful withdrawal from dobutamine [7 days]

Successful withdrawal from dobutamine with clinical stability

2. Worsening renal function [7 days]

Increase > 0.3 mg/dL in serum creatinine

3. Hyperkalemia [7 days]

Serum potassium > 5.5 mEq/L

4. Hypotension [7 days]

Systolic blood pressure < 80 mmHg

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