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| ID | Type | Description | Link |
|---|---|---|---|
| KNW-1-154/P/2/0 | Other Grant/Funding Number | Medical University of Silesia |
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Recall of some valsartan preparations. 88 patients enrolled and completed the observation. All patients are in continuous observation and are well.
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| Name | Class |
|---|---|
| Polpharma Pharmaceutical Company | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo pills to match valsartan tablets administered once daily |
|
| valsartan 80mg daily | Experimental | Valsartan 80mg tablet once daily |
|
| valsartan 160mg daily | Experimental | Valsartan 160mg tablet once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo/valsartan | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change in echocardiographically assessed left ventricle dimensions and left ventricle function | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewa Nowalany-Kozielska, MD PhD Associate Professor | Medical University of Silesia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| II Dept. of Cardiology in Zabrze Medical University of Silesia | Zabrze | Upper Silesia | 41-800 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19346662 | Background | 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. | |
| 20378999 |
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| ID | Term |
|---|---|
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
| 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. |
| 15486029 | Background | 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. |
| 25858003 | Derived | 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. |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |