HypertensionSTIPPARENCT01017835
Simvastatin in Patients With Isolated Arterial Hypertension
An observational study of Hypertension, run by Medical University of Lodz at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2009to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in the Department of Nephrology, Hypertension and Family Medicine,Clinical Hospital of Medical University of Lodz
Who may be able to join
- isolated hypertension (I or II class according to ESH guidelines 2009)
Who cannot join
- ischemic heart disease, prior percutaneous coronary intervention (PCI), prior coronary artery bypass grafting (CABG), heart failure, diabetes, hyperlipidemia, active smokers
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Departament of Nephrology, Hypertension and Family Medicine, Clinical Hospital of Medical University of Lodz
Lodz, 90-549
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Keywords
- statins, isolated hypertension, atherosclerosis, lipid profile
- Medical subject headings
- Hypertension, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Maciej Banach, MD PhD, Study chair, Departament of Hypertension , Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017835
- Sponsor's protocol ID
- 503-5139-2
- Acronym
- STIPPARE
- Status last verified
- Nov 2009
- First submitted
- 20 Nov 2009
- Last updated
- 23 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19555312Rysz 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.
PubMed 19368496Szadkowska 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.
PubMed 19217673
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin in the Treatment of Isolated Arterial hyPertension and Prevention of cARdiovascular Events
- ClinicalTrials.gov ID
- NCT01017835
- Acronym / sponsor ID
- STIPPARE / 503-5139-2
- Conditions
- Hypertension
- Keywords
- statins, isolated hypertension, atherosclerosis, lipid profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the Department of Nephrology, Hypertension and Family Medicine,Clinical Hospital of Medical University of Lodz
Key inclusion criteria (1 listed)
- isolated hypertension (I or II class according to ESH guidelines 2009)
Key exclusion criteria (1 listed)
- ischemic heart disease, prior percutaneous coronary intervention (PCI), prior coronary artery bypass grafting (CABG), heart failure, diabetes, hyperlipidemia, active smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2009.
- Background: PubMed 19555312Stepien 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.
- Background: PubMed 19368496Rysz 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.
- Background: PubMed 19217673Szadkowska 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.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Banach, MD PhD study chair
Departament of Hypertension , Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Michalska, MSc (501154853 ext. +48, michalska_marta84@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01017835, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2009.