Simvastatin in Patients With Isolated Arterial Hypertension (STIPPARE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Medical Universtity of Lodz.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01017835
First received: November 20, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Simvastatin in the Treatment of Isolated Arterial hyPertension and Prevention of cARdiovascular Events

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Biospecimen Retention:   Samples Without DNA

plasma


Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients hospitalized in the Department of Nephrology, Hypertension and Family Medicine,Clinical Hospital of Medical University of Lodz

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017835

Contacts
Contact: Marta Michalska, MSc 501154853 ext +48 michalska_marta84@wp.pl
Contact: Maciej Banach, MD PhD 604593040 ext +48 maciejbanach@aol.co.uk

Locations
Poland
Departament of Nephrology, Hypertension and Family Medicine, Clinical Hospital of Medical University of Lodz Recruiting
Lodz, Poland, 90-549
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Study Chair: Maciej Banach, MD PhD Departament of Hypertension , Medical University of Lodz
  More Information

Publications:
Responsible Party: Maciej Banach, Departament of Hypertension
ClinicalTrials.gov Identifier: NCT01017835     History of Changes
Other Study ID Numbers: 503-5139-2
Study First Received: November 20, 2009
Last Updated: November 20, 2009
Health Authority: Poland: Ethics Committee

Keywords provided by Medical Universtity of Lodz:
statins
isolated hypertension
atherosclerosis
lipid profile

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014