Status:
TERMINATED
Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients
Lead Sponsor:
Medical University of Silesia
Collaborating Sponsors:
Polpharma Pharmaceutical Company
Conditions:
First Time Dual Chamber Pacemaker Implantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 chambe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2019
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01805804
Start Date
January 1 2017
End Date
January 31 2019
Last Update
April 12 2023
Active Locations (1)
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1
II Dept. of Cardiology in Zabrze Medical University of Silesia
Zabrze, Upper Silesia, Poland, 41-800