Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

Phase 4

Terminated

• Conditions: First Time Dual Chamber Pacemaker Implantation
• Interventions: Drug: placebo/valsartan

• Registration Number: NCT01805804
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-02
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-06
• Study Start: 2017-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
valsartan 80mg daily	placebo/valsartan	Valsartan 80mg tablet once daily
valsartan 160mg daily	placebo/valsartan	Valsartan 160mg tablet once daily
Placebo	placebo/valsartan	Placebo pills to match valsartan tablets administered once daily

Primary Outcome Measures

Name	Time	Method
change in echocardiographically assessed left ventricle dimensions and left ventricle function	baseline and 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

II Dept. of Cardiology in Zabrze Medical University of Silesia; 🇵🇱 Zabrze, Upper Silesia, Poland