Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker
Overview
- Phase
- Phase 4
- Intervention
- placebo/valsartan
- Conditions
- First Time Dual Chamber Pacemaker Implantation
- Sponsor
- Medical University of Silesia
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- change in echocardiographically assessed left ventricle dimensions and left ventricle function
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Andrzej Tomasik MD PhD FESC
Doctor
Medical University of Silesia
Eligibility Criteria
Inclusion Criteria
- •informed written consent
- •age ≥ 18 years
- •first time pacemaker implantation for trifascicular block, atrioventricular second or third degree block
- •left ventricle ejection fraction ≥ 40%
Exclusion Criteria
- •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
Arms & Interventions
Placebo
Placebo pills to match valsartan tablets administered once daily
Intervention: placebo/valsartan
valsartan 80mg daily
Valsartan 80mg tablet once daily
Intervention: placebo/valsartan
valsartan 160mg daily
Valsartan 160mg tablet once daily
Intervention: placebo/valsartan
Outcomes
Primary Outcomes
change in echocardiographically assessed left ventricle dimensions and left ventricle function
Time Frame: baseline and 12 months
Secondary Outcomes
- 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)