Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Silesia
• Collaborator: Polpharma Pharmaceutical Company
• Treatments: Valsartan

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

• 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