HypertensionNCT02064218
Emerging Biomarkers in Hypertension
An observational study of Hypertension, run by University of Pavia at 1 site in Italy.
Trial summary
First of all to evaluate the relationship between non-conventional biomarkers and essential hypertension; then to evaluate the effects of various anti-hypertensive drugs on blood pressure control and non-conventional biomarkers in naive hypertensive patients Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Anti-hypertensive drugs
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Nov 2007to Jan 2014
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with naive essential hypertension aged < 65 years without previous cardiovascular events
Who may be able to join
- essential hypertension
- naive to treatment
- < 65 years
Who cannot join
- secondary hypertension
- previous cardiovascular events
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico S.Matteo Foundation
Pavia, 27100
Giuseppe Derosa, MD, PhD, +39 0382 502614, giuseppe.derosa@unipv.it
Pamela Maffioli, MD
About this study
Official title: Evaluation of Some Emerging Biomarkers of Cardiovascular Risk Stratification in Hypertensive Patients: a 5-years Follow-up
First of all to evaluate the relationship between non-conventional biomarkers and essential hypertension; then to evaluate the effects of various anti-hypertensive drugs on blood pressure control and non-conventional biomarkers in naive hypertensive patients
- Conditions
- Hypertension
- Being tested
- Anti-hypertensive drugs
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-hypertensive drugsDrug
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients | Hypertensive patients naive to hypertensive treatment Receives: Drug: Anti-hypertensive drugs | |
| healthy subjects | healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure reduction
- Systolic Blood Pressure (SBP)
- Diastolic Blood Pressure (DBP)
Measured: 5 years
Secondary outcomes (1)
Cardiovascular and metabolic biomarkers
- Lipoprotein (a) (Lp(a))
- sRAGE (soluble Receptor for Advanced Glycation End-products)
- sCD40L (soluble ligand of CD40)
- MPO (myeloperoxidase)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startNov 2007
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
- Investigators
- Giuseppe Derosa, MD, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064218
- Sponsor's protocol ID
- 20070002649
- Status last verified
- Nov 2007
- First submitted
- 11 Feb 2014
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. Barnidipine compared to lercanidipine in addition to losartan on endothelial damage and oxidative stress parameters in patients with hypertension and type 2 diabetes mellitus. BMC Cardiovasc Disord. 2016 Apr 12;16:66. doi: 10.1186/s12872-016-0237-z.
PubMed 27068332Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. Perindopril and barnidipine alone or combined with simvastatin on hepatic steatosis and inflammatory parameters in hypertensive patients. Eur J Pharmacol. 2015 Nov 5;766:31-6. doi: 10.1016/j.ejphar.2015.09.030. Epub 2015 Sep 25.
PubMed 26407654Derosa G, Mugellini A, Querci F, Franzetti I, Pesce RM, D'Angelo A, Maffioli P. Barnidipine or Lercanidipine on Echocardiographic Parameters in Hypertensive, Type 2 Diabetics with Left Ventricular Hypertrophy: A Randomized Clinical Trial. Sci Rep. 2015 Aug 5;5:12603. doi: 10.1038/srep12603.
PubMed 26243165Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. A study about the relevance of adding acetylsalicylic acid in primary prevention in subjects with type 2 diabetes mellitus: effects on some new emerging biomarkers of cardiovascular risk. Cardiovasc Diabetol. 2015 Jul 30;14:95. doi: 10.1186/s12933-015-0254-8.
PubMed 26223257Derosa G, Romano D, Bianchi L, D'Angelo A, Maffioli P. The effects of canrenone on inflammatory markers in patients with metabolic syndrome. Ann Med. 2015 Feb;47(1):47-52. doi: 10.3109/07853890.2014.969303. Epub 2014 Oct 16.
PubMed 25319120
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Some Emerging Biomarkers of Cardiovascular Risk Stratification in Hypertensive Patients: a 5-years Follow-up
- ClinicalTrials.gov ID
- NCT02064218
- Acronym / sponsor ID
- 20070002649
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- Nov 2007
- Primary completion
- Jan 2014 (actual)
- First posted
- 17 Feb 2014 (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.
First of all to evaluate the relationship between non-conventional biomarkers and essential hypertension; then to evaluate the effects of various anti-hypertensive drugs on blood pressure control and non-conventional biomarkers in naive hypertensive patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | – | Drug: Anti-hypertensive drugsHypertensive patients naive to hypertensive treatment |
| healthy subjects | – | –healthy subjects |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with naive essential hypertension aged < 65 years without previous cardiovascular events
Key inclusion criteria (3 listed)
- essential hypertension
- naive to treatment
- < 65 years
Key exclusion criteria (2 listed)
- secondary hypertension
- previous cardiovascular events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-hypertensive drugs | Drug | Hypertensive patients |
Primary outcome
Blood pressure reduction
Time frame: 5 years
* Systolic Blood Pressure (SBP) * Diastolic Blood Pressure (DBP)
1 secondary outcome
Cardiovascular and metabolic biomarkers
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Derived from this study: PubMed 27068332Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. Barnidipine compared to lercanidipine in addition to losartan on endothelial damage and oxidative stress parameters in patients with hypertension and type 2 diabetes mellitus. BMC Cardiovasc Disord. 2016 Apr 12;16:66. doi: 10.1186/s12872-016-0237-z.
- Derived from this study: PubMed 26407654Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. Perindopril and barnidipine alone or combined with simvastatin on hepatic steatosis and inflammatory parameters in hypertensive patients. Eur J Pharmacol. 2015 Nov 5;766:31-6. doi: 10.1016/j.ejphar.2015.09.030. Epub 2015 Sep 25.
- Derived from this study: PubMed 26243165Derosa G, Mugellini A, Querci F, Franzetti I, Pesce RM, D'Angelo A, Maffioli P. Barnidipine or Lercanidipine on Echocardiographic Parameters in Hypertensive, Type 2 Diabetics with Left Ventricular Hypertrophy: A Randomized Clinical Trial. Sci Rep. 2015 Aug 5;5:12603. doi: 10.1038/srep12603.
- Derived from this study: PubMed 26223257Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. A study about the relevance of adding acetylsalicylic acid in primary prevention in subjects with type 2 diabetes mellitus: effects on some new emerging biomarkers of cardiovascular risk. Cardiovasc Diabetol. 2015 Jul 30;14:95. doi: 10.1186/s12933-015-0254-8.
- Derived from this study: PubMed 25319120Derosa G, Romano D, Bianchi L, D'Angelo A, Maffioli P. The effects of canrenone on inflammatory markers in patients with metabolic syndrome. Ann Med. 2015 Feb;47(1):47-52. doi: 10.3109/07853890.2014.969303. Epub 2014 Oct 16.
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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.
Giuseppe Derosa, MD, PhD principal investigator
University of Pavia
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 University of Pavia at 1 site in Italy.
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 3 inclusion and 2 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 17 Feb 2014. 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 Italy. 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 Giuseppe Derosa, MD, PhD (+39 0382 502614, giuseppe.derosa@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure reduction (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064218, which also lists 5 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 17 Feb 2014.