Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

April 10, 2023 updated by: Andrzej Tomasik MD PhD FESC, Medical University of Silesia

Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Upper Silesia
      • Zabrze, Upper Silesia, Poland, 41-800
        • II Dept. of Cardiology in Zabrze Medical University of Silesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo pills to match valsartan tablets administered once daily
Drug: placebo/valsartan
Other Names:
  • Diovan
  • Valsartan
  • Other names:
  • Axudan
  • Vanatex
Experimental: valsartan 80mg daily
Valsartan 80mg tablet once daily
Drug: placebo/valsartan
Other Names:
  • Diovan
  • Valsartan
  • Other names:
  • Axudan
  • Vanatex
Experimental: valsartan 160mg daily
Valsartan 160mg tablet once daily
Drug: placebo/valsartan
Other Names:
  • Diovan
  • Valsartan
  • Other names:
  • Axudan
  • Vanatex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in echocardiographically assessed left ventricle dimensions and left ventricle function
Time Frame: baseline and 12 months
baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in plasma level of matrix metalloproteinase 9
Time Frame: baseline and 12 months
baseline and 12 months
change in plasma level of NTproBNP
Time Frame: baseline and 12 months
baseline and 12 months
change in atrial arrhythmia burden assessed from pacemaker memory
Time Frame: baseline and 12 months
baseline and 12 months
change in the rate of occurrence of any major adverse cardiovascular event
Time Frame: 2 weeks, 3 months, 6 months, 9 months and 12 months
2 weeks, 3 months, 6 months, 9 months and 12 months
change in plasma level of tissue necrosis factor alpha
Time Frame: baseline and 12 months
baseline and 12 months
change in plasma level of tissue inhibitor of matrix metalloproteinase 3
Time Frame: baseline and 12 months
baseline and 12 months
change in distance walked during six minute walking test
Time Frame: baseline and 12 months
baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Polpharma Pharmaceutical Company

Investigators

  • Study Director: Ewa Nowalany-Kozielska, MD PhD Associate Professor, Medical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

March 2, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2012
  • KNW-1-154/P/2/0 (Other Grant/Funding Number: Medical University of Silesia)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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