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
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
- 否
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
Losartan 50 mg bid orally
干预措施: Losartan (Drug)
Placebo
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
Marcelo Eidi Ochiai
Ph.D.
InCor Heart Institute
