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Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

M

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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