Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker
| Registry | NCT01805804 |
|---|---|
| Status | Terminated - Recall of some valsartan preparations. 88 patients enrolled and completed the observation. All patients are in continuous observation and are well. |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 88 (Estimated) |
| Sponsor | Medical University of Silesia (Other); collaborators: Polpharma Pharmaceutical Company |
| Conditions | First Time Dual Chamber Pacemaker Implantation |
| Interventions | placebo/valsartan (Drug) |
| Dates | start 2017-01-01, primary completion 2019-01-31, completion 2019-01-31, first posted 2013-03-06, last updated 2023-04-12 |
| Locations | 1 site in Poland |
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All trials for First Time Dual Chamber Pacemaker Implantation All trials of placebo/valsartan
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Drug: placebo/valsartan | Placebo pills to match valsartan tablets administered once daily |
| valsartan 80mg daily | Experimental | Drug: placebo/valsartan | Valsartan 80mg tablet once daily |
| valsartan 160mg daily | Experimental | Drug: placebo/valsartan | Valsartan 160mg tablet once daily |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| II Dept. of Cardiology in Zabrze Medical University of Silesia | Zabrze, Upper Silesia | Poland |