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Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

Primary Purpose

First Time Dual Chamber Pacemaker Implantation

Status

Terminated

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

placebo/valsartan

About this trial

This is an interventional prevention trial for First Time Dual Chamber Pacemaker Implantation focused on measuring dual chamber pacing, left ventricle remodeling, valsartan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

II Dept. of Cardiology in Zabrze Medical University of Silesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

valsartan 80mg daily

valsartan 160mg daily

Arm Description

Placebo pills to match valsartan tablets administered once daily

Valsartan 80mg tablet once daily

Valsartan 160mg tablet once daily

Outcomes

Primary Outcome Measures

change in echocardiographically assessed left ventricle dimensions and left ventricle function

Secondary Outcome Measures

change in plasma level of matrix metalloproteinase 9

change in plasma level of NTproBNP

change in atrial arrhythmia burden assessed from pacemaker memory

change in the rate of occurrence of any major adverse cardiovascular event

change in plasma level of tissue necrosis factor alpha

change in plasma level of tissue inhibitor of matrix metalloproteinase 3

change in distance walked during six minute walking test

Full Information

NCT ID

NCT01805804

First Posted

March 2, 2013

Last Updated

April 10, 2023

Sponsor

Medical University of Silesia

Collaborators

Polpharma Pharmaceutical Company

1. Study Identification

Unique Protocol Identification Number

NCT01805804

Brief Title

Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

Recall of some valsartan preparations. 88 patients enrolled and completed the observation. All patients are in continuous observation and are well.

Study Start Date

January 2017 (undefined)

Primary Completion Date

January 31, 2019 (Actual)

Study Completion Date

January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Silesia

Collaborators

Polpharma Pharmaceutical Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

First Time Dual Chamber Pacemaker Implantation

Keywords

dual chamber pacing, left ventricle remodeling, valsartan

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo pills to match valsartan tablets administered once daily

Arm Title

valsartan 80mg daily

Arm Type

Experimental

Arm Description

Valsartan 80mg tablet once daily

Arm Title

valsartan 160mg daily

Arm Type

Experimental

Arm Description

Valsartan 160mg tablet once daily

Intervention Type

Drug

Intervention Name(s)

placebo/valsartan

Other Intervention Name(s)

Valsartan, Other names:, Diovan, Axudan, Vanatex

Primary Outcome Measure Information:

Title

change in echocardiographically assessed left ventricle dimensions and left ventricle function

Time Frame

baseline and 12 months

Secondary Outcome Measure Information:

Title

change in plasma level of matrix metalloproteinase 9

Time Frame

baseline and 12 months

Title

change in plasma level of NTproBNP

Time Frame

baseline and 12 months

Title

change in atrial arrhythmia burden assessed from pacemaker memory

Time Frame

baseline and 12 months

Title

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

Title

change in plasma level of tissue necrosis factor alpha

Time Frame

baseline and 12 months

Title

change in plasma level of tissue inhibitor of matrix metalloproteinase 3

Time Frame

baseline and 12 months

Title

change in distance walked during six minute walking test

Time Frame

baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ewa Nowalany-Kozielska, MD PhD Associate Professor

Organizational Affiliation

Medical University of Silesia

Official's Role

Study Director

Facility Information:

Facility Name

II Dept. of Cardiology in Zabrze Medical University of Silesia

City

Zabrze

State/Province

Upper Silesia

ZIP/Postal Code

41-800

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

19346662

Citation

Suzuki H, Geshi E, Nanjyo S, Nakano H, Yamazaki J, Sato N, Tanaka K, Takano T, Yagi H, Shibata T, Mochizuki S, Katagiri T. Inhibitory effect of valsartan against progression of left ventricular dysfunction after myocardial infarction: T-VENTURE study. Circ J. 2009 May;73(5):918-24. doi: 10.1253/circj.cj-08-0959. Epub 2009 Apr 2.

Results Reference

background

PubMed Identifier

20378999

Citation

Miyazaki S, Kasai T, Miyauchi K, Miyazaki T, Akimoto Y, Takagi A, Aihara K, Kawamura M, Suwa S, Kojima S, Sumiyoshi M, Daida H. Changes of matrix metalloproteinase-9 level is associated with left ventricular remodeling following acute myocardial infarction among patients treated with trandolapril, valsartan or both. Circ J. 2010 Jun;74(6):1158-64. doi: 10.1253/circj.cj-09-0412. Epub 2010 Apr 6.

Results Reference

background

PubMed Identifier

15486029

Citation

Garcia RA, Brown KL, Pavelec RS, Go KV, Covell JW, Villarreal FJ. Abnormal cardiac wall motion and early matrix metalloproteinase activity. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1080-7. doi: 10.1152/ajpheart.00860.2004. Epub 2004 Oct 14.

Results Reference

background

PubMed Identifier

25858003

Citation

Tomasik A, Jachec W, Wojciechowska C, Kawecki D, Bialkowska B, Romuk E, Gabrysiak A, Birkner E, Kalarus Z, Nowalany-Kozielska E. Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial. Contemp Clin Trials. 2015 May;42:239-43. doi: 10.1016/j.cct.2015.03.015. Epub 2015 Apr 7.

Results Reference

derived

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Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

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