Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-01-31

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.

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Detailed Description

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Conditions

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First Time Dual Chamber Pacemaker Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo pills to match valsartan tablets administered once daily

Group Type PLACEBO_COMPARATOR

placebo/valsartan

Intervention Type DRUG

valsartan 80mg daily

Valsartan 80mg tablet once daily

Group Type EXPERIMENTAL

placebo/valsartan

Intervention Type DRUG

valsartan 160mg daily

Valsartan 160mg tablet once daily

Group Type EXPERIMENTAL

placebo/valsartan

Intervention Type DRUG

Interventions

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placebo/valsartan

Intervention Type DRUG

Other Intervention Names

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Valsartan Other names: Diovan Axudan Vanatex

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No