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临床试验/NCT01857999
NCT01857999已完成4 期

Short-term add-on Therapy With Angiotensin Receptor Blocker for End-stage Inotrope-dependent Heart Failure Patients: B-type Natriuretic Peptide Reduction in a Randomized Clinical Trial

InCor Heart Institute1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
21
试验地点
1
主要终点
B-type natriuretic peptide

研究概览

简要总结

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.

详细描述

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.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • hospitalization for decompensated heart failure
  • dobutamine dependence
  • ejection fraction < 0.45
  • taking angiotensin-converting enzyme inhibitor

排除标准

  • 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

研究组 & 干预措施

Losartan

Experimental

Losartan 50 mg bid orally

干预措施: Losartan (Drug)

Placebo

Placebo Comparator

Placebo 1 pill bid orally

干预措施: Placebo (Drug)

结局指标

主要结局

B-type natriuretic peptide

时间窗: 7 days

Serum B-type natriuretic peptide

次要结局

  • Successful withdrawal from dobutamine(7 days)
  • Worsening renal function(7 days)
  • Hyperkalemia(7 days)
  • Hypotension(7 days)

研究者

发起方
InCor Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcelo Eidi Ochiai

Ph.D.

InCor Heart Institute

研究点 (1)

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