First Time Dual Chamber Pacemaker Implantation
Conditions
Keywords
dual chamber pacing, left ventricle remodeling, valsartan
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.
Interventions
DRUGplacebo/valsartan
Sponsors
Polpharma Pharmaceutical Company
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in echocardiographically assessed left ventricle dimensions and left ventricle function | baseline and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 matrix metalloproteinase 9 | 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 |
| change in plasma level of tissue necrosis factor alpha | baseline and 12 months |
Countries
Poland
Outcome results
None listed