Simvastatin in Patients With Isolated Arterial Hypertension

Brief Summary

Official Title: “Simvastatin in the Treatment of Isolated Arterial hyPertension and Prevention of cARdiovascular Events”

The purpose of this study is to determine whether combined therapy with simvastatin and hypotensive drugs (ACEI or ARB) may decrease the blood pressure. Moreover, we would like to assess the influence of isolated hypertension on endothelial injury, and on the development of atherosclerosis.

  • Study Type: Observational
  • Study Design: Observational Model: Case Control, Time Perspective: Prospective
  • Study Primary Completion Date: June 2011

Detailed Clinical Trial Description

Hypertension is one of the most important predictors of cardiovascular diseases (CVD). Due to the fact that hypertension frequently coexists with hypercholesterolemia and diabetes which increase the risk of CVDs development, it is advisable to use the optimal combined therapy (hypotensive + hypolipidemic + hypoglycemic)in this group of patients. Statins are the most effective and widely used drugs for the treatment of hypercholesterolemia. According to the available experimental and clinical data they may decrease the blood pressure (BP) in normotensive and hypertensive patients. However, it is still difficult to determine to what degree the reduction of both blood pressure and cardiovascular risk is due to hypotensive or hypolipidemic/pleiotropic effects of statins.

Arms, Groups and Cohorts in this Clinical Trial

  • statin treatment, isolated hypertension
    • treatment with statins, patients with isolated hypertension, with no hyperlipidemia, no diabetes, no smoking
  • placebo treatment, isolated hypertension
    • treatment with placebo, patients with isolated hypertension, with no hyperlipidemia, no diabetes, no smoking

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • isolated hypertension (I or II class according to ESH guidelines 2009)

Exclusion Criteria

  • ischemic heart disease, prior percutaneous coronary intervention (PCI), prior coronary artery bypass grafting (CABG), heart failure, diabetes, hyperlipidemia, active smokers

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Medical Universtity of Lodz
  • Provider of Information About this Clinical Study
    • Maciej Banach, Departament of Hypertension
  • Overall Official(s)
    • Maciej Banach, MD PhD, Study Chair, Departament of Hypertension , Medical University of Lodz
  • Overall Contact(s)
    • Marta Michalska, MSc, 501154853,


Stepien M, Banach M, Mikhailidis DP, Gluba A, Kjeldsen SE, Rysz J. Role and significance of statins in the treatment of hypertensive patients. Curr Med Res Opin. 2009 Aug;25(8):1995-2005. doi: 10.1185/03007990903098081. Review.

Rysz J, Aronow WS, Stolarek RS, Hannam S, Mikhailidis DP, Banach M. Nephroprotective and clinical potential of statins in dialyzed patients. Expert Opin Ther Targets. 2009 May;13(5):541-50. doi: 10.1517/14728220902882130 .

Szadkowska I, Stanczyk A, Aronow WS, Kowalski J, Pawlicki L, Ahmed A, Banach M. Statin therapy in the elderly: a review. Arch Gerontol Geriatr. 2010 Jan-Feb;50(1):114-8. doi: 10.1016/j.archger.2008.12.012. Epub 2009 Feb 13. Review.


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