Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

Condition(s) targeted: First Time Dual Chamber Pacemaker Implantation

Intervention: placebo/valsartan (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Medical University of Silesia

Official(s) and/or principal investigator(s):
Ewa Nowalany-Kozielska, MD PhD Associate Professor, Study Director, Affiliation: Medical University of Silesia

Overall contact:
Beata Bialkowska, MD, Phone: 0048323732372, Email: beata.bialkowska@sum.edu.pl

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: change in echocardiographically assessed left ventricle dimensions and left ventricle function

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Beata Bialkowska, MD, Phone: 0048323732372, Email: beata.bialkowska@sum.edu.pl

Dept. of Biochemistry Medical University of Silesia, Zabrze, Upper Silesia 41-800, Poland; Not yet recruiting
Ewa Birkner, Professor, Phone: 0048322722041
Ewa Romuk, PhD, Sub-Investigator

II Dept. of Cardiology in Zabrze Medical University of Silesia, Zabrze, Upper Silesia 41-800, Poland; Not yet recruiting
Andrzej R Tomasik, MD PhD FESC, Principal Investigator
Beata Bialkowska, MD, Sub-Investigator
Wojciech Jachec, MD PhD, Sub-Investigator
Celina Wojciechowska, MD PhD, Sub-Investigator
Damian Kawecki, MD PhD, Sub-Investigator
Grzegorz Kubiak, MD, Sub-Investigator
Katarzyna Wozniak, MD, Sub-Investigator

Medical Laboratory Dr med. Fryda, Zabrze, Upper Silesia 41-800, Poland; Not yet recruiting
Artur Gabrysiak, MBA, Phone: 0048323732330

Silesian Center for Heart Diseases, Zabrze, Upper Silesia 41-800, Poland; Not yet recruiting
Zbigniew Kalarus, MD PhD Professor, Phone: 0048323733682
Zbigniew Kalarus, MD PhD Professor, Principal Investigator

Related publications:

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. Epub 2009 Apr 2.

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. Epub 2010 Apr 6.

García 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. Epub 2004 Oct 14.

Starting date: October 2015
Last updated: August 17, 2015