HypertensionNCT00497016
Does Statin Therapy Reduce Sympathoexcitation in Hypertension?
A study testing atorvastatin 80 mg in people with Hypertension, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
A number of patients with hypertension have increased central sympathetic activity. Statins seem to inhibit central sympathetic output. This study assesses the effect of statins on central sympathetic activity in hypertension patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- atorvastatin 80 mg
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2007to Mar 2008
- Phase
- Interventional
- 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 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- (Known) hypertension
- stable drug therapy for at least 2 months
- age 18-70 jaar
- BMI 18-35 kg/m2
- Sinusrhythm
Who cannot join
- Recent cardiovascular event <6 mnd
- Plasma Creatinin:
- female: >120 mmol/L
- male: >133 mmol/L
- use of:
- tricyclic antidepressants
Show all 9Show fewer
- alpha-1 -and/or alpha-2 blockers
- disease of the autonomic nervous system (Parkinsons disease, Shy- Drager syndrome, etc)
- Albuminuria >300 mg/dag
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center Nijmegen
Nijmegen, 6500 HB
About this study
A number of patients with hypertension have increased central sympathetic activity. Statins seem to inhibit central sympathetic output. This study assesses the effect of statins on central sympathetic activity in hypertension patients.
- Conditions
- Hypertension
- Being tested
- atorvastatin 80 mg
- Keywords
- hypertension, statin, sympathetic
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatin 80 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change in central sympathetic activity
Secondary outcomes (1)
change in cholesterol levels, renin and aldosteron
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startMay 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Cees J Tack, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497016
- Sponsor's protocol ID
- HTSTAT
- Status last verified
- Sep 2008
- First submitted
- 4 Jul 2007
- Last updated
- 30 Sep 2008
- Results posted
- No
Publications
Gomes ME, Tack CJ, Verheugt FW, Smits P, Lenders JW. Sympathoinhibition by atorvastatin in hypertensive patients. Circ J. 2010 Nov;74(12):2622-6. doi: 10.1253/circj.cj-10-0427. Epub 2010 Oct 9.
PubMed 20953062
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Statin Therapy Reduce Sympathoexcitation in Hypertension?
- ClinicalTrials.gov ID
- NCT00497016
- Acronym / sponsor ID
- HTSTAT
- Conditions
- Hypertension
- Keywords
- hypertension, statin, sympathetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- May 2007
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Jul 2007 (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.
A number of patients with hypertension have increased central sympathetic activity. Statins seem to inhibit central sympathetic output. This study assesses the effect of statins on central sympathetic activity in hypertension patients.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (Known) hypertension
- stable drug therapy for at least 2 months
- age 18-70 jaar
- BMI 18-35 kg/m2
- Sinusrhythm
Key exclusion criteria (9 listed)
- Recent cardiovascular event <6 mnd
- Plasma Creatinin:
- female: >120 mmol/L
- male: >133 mmol/L
- use of:
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 |
|---|---|---|
| atorvastatin 80 mg | Drug | – |
Primary outcome
change in central sympathetic activity
1 secondary outcome
change in cholesterol levels, renin and aldosteron
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2008.
- Derived from this study: PubMed 20953062Gomes ME, Tack CJ, Verheugt FW, Smits P, Lenders JW. Sympathoinhibition by atorvastatin in hypertensive patients. Circ J. 2010 Nov;74(12):2622-6. doi: 10.1253/circj.cj-10-0427. Epub 2010 Oct 9.
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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.
Cees J Tack, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin 80 mg in people with Hypertension, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 30 Sep 2008. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in central sympathetic activity. 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 NCT00497016, which also lists 1 linked publication.
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 30 Sep 2008.