Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker

Conditions
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First Time Dual Chamber Pacemaker Implantation

Intervention / Treatment
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* Drug: placebo/valsartan


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo pills to match valsartan tablets administered once daily | Drug: placebo/valsartan<br> <br> * Other names: Vanatex;|
| Experimental: valsartan 80mg daily<br>Valsartan 80mg tablet once daily | Drug: placebo/valsartan<br> <br> * Other names: Vanatex;|
| Experimental: valsartan 160mg daily<br>Valsartan 160mg tablet once daily | Drug: placebo/valsartan<br> <br> * Other names: Vanatex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in echocardiographically assessed left ventricle dimensions and left ventricle function |  | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual chamber pacing, left ventricle remodeling, valsartan