The ACEi SwitchBack Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- proportion of patients on ARB who are switched back to ACEi and\ who tolerate ACEi
研究概览
简要总结
ACE inhibitors have been studied extensively in the treatment of heart failure and have been shown to be beneficial in all its stages. Studies with the use of angiotensin receptor blockers (ARBs) in chronic heart failure have not shown equivalent results. Many patients are on an ARB for a variety of reasons. Some of these may have had cough as a symptom of heart failure and not due to medication side effect. According to guidelines, angiotensin converting enzyme inhibitors (ACEi) are still first-line therapy in the treatment of heart failure. As ACEi have been extensively studied showing improvement in morbidity and mortality all patients should be on this treatment unless absolutely contraindicated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heart failure patients who have indications for ACEi but are currently on ARBs with no absolute contraindications to ACEi
- •patients with an ejection fraction of < or = 35% verified in the last 12 months by echo, angio, or nuc med who are NYHA class I to IV and followed in a heart failure clinic for three months
- •on beta-blockers, unless contra-indicated
- •stable on current meds for 3 months (except dose of diuretics)
- •able to give informed consent
排除标准
- •documented angioedema/anaphylaxis with prior ACEi use
- •documented worsening renal failure, hyperkalemia, cough and gastrointestinal symptoms that are definitely believed to be due to ACEi
- •potassium >5.0 mmol/L
结局指标
主要结局
proportion of patients on ARB who are switched back to ACEi and\ who tolerate ACEi
时间窗: 6 months
Patients with heart failure who are on ARB who do not clear contra-indication to ACEi will be switched to an ACei. their tolrance to this will be evaluated
次要结局
未报告次要终点