Title
Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients
Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker
Phase
Phase 4Lead Sponsor
Silesian University of MedicineStudy Type
InterventionalStatus
TerminatedIndication/Condition
First Time Dual Chamber Pacemaker ImplantationIntervention/Treatment
valsartan ...Study Participants
88Dual 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.
Placebo pills to match valsartan tablets administered once daily
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
