Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

Medical University of Silesia

Status and phase: Terminated; Phase 4

Conditions: First Time Dual Chamber Pacemaker Implantation

Treatments: Drug: placebo/valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01805804

KNW-1-154/P/2/0 (Other Grant/Funding Number)

01/2012

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo pills to match valsartan tablets administered once daily

Treatment:

Drug: placebo/valsartan

valsartan 80mg daily

Experimental group

Description:

Valsartan 80mg tablet once daily

Treatment:

Drug: placebo/valsartan

valsartan 160mg daily

Experimental group

Description:

Valsartan 160mg tablet once daily

Treatment:

Drug: placebo/valsartan