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Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

This study is not yet open for participant recruitment.
Verified March 2013 by Medical University of Silesia
Sponsor:
Collaborator:
Polpharma Pharmaceutical Company
Information provided by (Responsible Party):
Andrzej Tomasik MD PhD FESC, Medical University of Silesia
ClinicalTrials.gov Identifier:
NCT01805804
First received: March 2, 2013
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
First Time Dual Chamber Pacemaker Implantation
 Drug: placebo/valsartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Is There a Possibility to Pharmacologically Prevent Left Ventricle Remodeling in Patients With Pacemaker? Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker

Resource links provided by NLM:

Drug Information available for: Valsartan
U.S. FDA Resources

Further study details as provided by Medical University of Silesia:

Primary Outcome Measures:
  • change in echocardiographically assessed left ventricle dimensions and left ventricle function [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in plasma level of matrix metalloproteinase 9 [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change in plasma level of NTproBNP [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change in atrial arrhythmia burden assessed from pacemaker memory [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • change in plasma level of tissue necrosis factor alpha [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change in plasma level of tissue inhibitor of matrix metalloproteinase 3 [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change in distance walked during six minute walking test [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo pills to match valsartan tablets administered once daily
 Drug: placebo/valsartan
Other Names:
  • Valsartan
  • Other names:
  • Diovan
  • Axudan
  • Vanatex
Experimental: valsartan 80mg daily Drug: placebo/valsartan
Other Names:
  • Valsartan
  • Other names:
  • Diovan
  • Axudan
  • Vanatex
Experimental: valsartan 160mg daily Drug: placebo/valsartan
Other Names:
  • Valsartan
  • Other names:
  • Diovan
  • Axudan
  • Vanatex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805804

Contacts
Contact: Beata Bialkowska, MD 0048323732372 beata.bialkowska@sum.edu.pl

Locations
Poland
II Dept. of Cardiology in Zabrze Medical University of Silesia Not yet recruiting
Zabrze, Upper Silesia, Poland, 41-800
Principal Investigator: Andrzej R Tomasik, MD PhD FESC            
Sub-Investigator: Beata Bialkowska, MD            
Sub-Investigator: Wojciech Jachec, MD PhD            
Sub-Investigator: Celina Wojciechowska, MD PhD            
Sub-Investigator: Damian Kawecki, MD PhD            
Sub-Investigator: Grzegorz Kubiak, MD            
Sub-Investigator: Katarzyna Wozniak, MD            
Silesian Center for Heart Diseases Not yet recruiting
Zabrze, Upper Silesia, Poland, 41-800
Contact: Zbigniew Kalarus, MD PhD Professor     0048323733682        
Principal Investigator: Zbigniew Kalarus, MD PhD Professor            
Dept. of Biochemistry Medical University of Silesia Not yet recruiting
Zabrze, Upper Silesia, Poland, 41-800
Contact: Ewa Birkner, Professor     0048322722041        
Sub-Investigator: Ewa Romuk, PhD            
Medical Laboratory Dr med. Fryda Not yet recruiting
Zabrze, Upper Silesia, Poland, 41-800
Contact: Artur Gabrysiak, MBA     0048323732330        
Sponsors and Collaborators
Medical University of Silesia
Polpharma Pharmaceutical Company
Investigators
Study Director: Ewa Nowalany-Kozielska, MD PhD Associate Professor Medical University of Silesia
  More Information

Publications:

Responsible Party: Andrzej Tomasik MD PhD FESC, Doctor, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT01805804     History of Changes
Other Study ID Numbers: 01/2012, KNW-1-154/P/2/0
Study First Received: March 2, 2013
Last Updated: March 4, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Silesia:
dual chamber pacing, left ventricle remodeling, valsartan

Additional relevant MeSH terms:
Ventricular Remodeling
Pathological Conditions, Anatomical
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013