Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- change in echocardiographically assessed left ventricle dimensions and left ventricle function
研究概览
简要总结
Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. The investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve months long follow up in comparison with placebo. Echocardiographic assessment of left ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP and distance in meters during six minute walking test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed written consent
- •age ≥ 18 years
- •first time pacemaker implantation for trifascicular block, atrioventricular second or third degree block
- •left ventricle ejection fraction ≥ 40%
排除标准
- •significant valvular heart disease
- •ischaemic heart disease requiring further revascularization
- •symptomatic hypotension
- •orthostatic disorders
- •pregnancy, breast feeding, child bearing potential
- •previous use of angiotensin receptor blocking agents
- •known hypersensitivity to valsartan
- •significant liver disorders
- •significant renal disorders, including renal artery stenosis
- •hyperaldosteronism
- •chronic use of nonsteroid antiinflammatory drugs
- •chronic use of lithium salts
- •Patient's reluctance or disability to obey protocol and/or follow the scheduled visits
- •any significant disease to reduce the expected life duration < 12 months
- •participation in any other trial within the last 30 days before randomization
- •any situation that would put more risk on patient
研究组 & 干预措施
Placebo
Placebo pills to match valsartan tablets administered once daily
干预措施: placebo/valsartan (Drug)
valsartan 80mg daily
Valsartan 80mg tablet once daily
干预措施: placebo/valsartan (Drug)
valsartan 160mg daily
Valsartan 160mg tablet once daily
干预措施: placebo/valsartan (Drug)
结局指标
主要结局
change in echocardiographically assessed left ventricle dimensions and left ventricle function
时间窗: baseline and 12 months
次要结局
- change in plasma level of matrix metalloproteinase 9(baseline and 12 months)
- change in plasma level of NTproBNP(baseline and 12 months)
- change in atrial arrhythmia burden assessed from pacemaker memory(baseline and 12 months)
- change in the rate of occurrence of any major adverse cardiovascular event(2 weeks, 3 months, 6 months, 9 months and 12 months)
- change in plasma level of tissue necrosis factor alpha(baseline and 12 months)
- change in plasma level of tissue inhibitor of matrix metalloproteinase 3(baseline and 12 months)
- change in distance walked during six minute walking test(baseline and 12 months)
研究者
Andrzej Tomasik MD PhD FESC
Doctor
Medical University of Silesia