Comparative Effects of Nebivolol and Carvedilol on Diastolic Function of the Left Ventricle in the Elderly Heart Failure Patients With Preserved Ejection Fraction: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')
研究概览
简要总结
Heart failure (HF) is a common and disabling condition in the elderly. Randomized clinical trials and meta-analyses have clearly demonstrated that long-term use of β blockers improves the outcomes of patients with HF. However, limited data have been available on the treatment of HF with preserved ejection fraction (EF) in the elderly. No study has specifically compared the relative effectiveness of carvedilol and nebivolol in treating HF in old age patients with preserved EF.
详细描述
This trial is a prospective, randomized, open-label, active controlled study designed to investigate effects of nebivolol and carvedilol on diastolic function of the left ventricle (LV) in the elderly HF patients with preserved EF.
Patients will be included in the study if they had LVEF ≥ 40%, NYHA functional class I, II or III, and clinical stability without hospital admission for HF in the preceding 3 months.
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
- 70 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than 70 years
排除标准
- •contraindication to the study drug
研究组 & 干预措施
Nebivolol
Nebivolol 10mg, once a day
干预措施: Nebivolol (Drug)
Carvedilol
Carvedilol 25mg, twice a day
干预措施: Carvedilol (Drug)
结局指标
主要结局
the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')
时间窗: 12 months
次要结局
未报告次要终点
研究者
Kyungil Park
Assistant Professor
Dong-A University