HypertensionPhase 4MBRACENCT00966199
The Effects of Blood Pressure Reduction on Cerebral Perfusion and Cognition in the Elderly Population
A Phase 4 study testing anti-hypertensive medication in people with Hypertension, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine if a reduction in systolic blood pressure induced by anti-hypertensive medication results in changes in cerebral perfusion and cognition in hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive medication for 8-12 weeks. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- anti-hypertensive medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Dec 2013
- Phase
- Phase 4
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age >= 70 years
- Systolic office blood pressure >= 160 mmHg
- Systolic home blood pressure >= 155 mmHg
Who cannot join
- Diabetes Mellitus
- Atrial fibrillation
- Dementia
- Renal failure requiring dialysis
- Life expectancy of less than 1 year
- Disabling stroke
- Contraindication for MRI or anti-hypertensive medication
- Systolic blood pressure > 220 mmHg
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University
Nijmegen, Gelderland, 6500HB
Jaap C Sijbesma, MD, 0243616772 ext. +31, J.Sijbesma@ger.umcn.nl
Jaap C Sijbesma, MD
About this study
Official title: Medication Induced Blood Pressure Reduction; Assessment of Cerebral Perfusion and Cognition in Hypertensive Elderly
The purpose of this study is to determine if a reduction in systolic blood pressure induced by anti-hypertensive medication results in changes in cerebral perfusion and cognition in hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive medication for 8-12 weeks. Changes in cerebral perfusion and cognition will be assessed before and after treatment.
- Conditions
- Hypertension
- Being tested
- anti-hypertensive medication
- Keywords
- blood pressure, aging, cerebrovascular circulation, hypertension
- 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 medicationDrug
8-12 weeks of anti-hypertensive treatment with 2 weekly titration using registered hypertensive medication
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive elderly | Experimental | community dwelling hypertensive elderly from general practices Receives: Drug: anti-hypertensive medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Measured: T1, 8-12 weeks of treatment, T2
Secondary outcomes (1)
Cognitive functioning assessed by neuropsychological testing
Measured: T1, 8-12 weeks of treatment, T2-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Investigators
- Jurgen A Claassen, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966199
- Sponsor's protocol ID
- MBRACE
- Other IDs
- 2008B113
- Acronym
- MBRACE
- Status last verified
- Aug 2009
- First submitted
- 17 Aug 2009
- Last updated
- 26 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Induced Blood Pressure Reduction; Assessment of Cerebral Perfusion and Cognition in Hypertensive Elderly
- ClinicalTrials.gov ID
- NCT00966199
- Acronym / sponsor ID
- MBRACE / MBRACE
- Conditions
- Hypertension
- Keywords
- blood pressure, aging, cerebrovascular circulation, hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- Sep 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Aug 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 if a reduction in systolic blood pressure induced by anti-hypertensive medication results in changes in cerebral perfusion and cognition in hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive medication for 8-12 weeks. Changes in cerebral perfusion and cognition will be assessed before and after treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive elderly | Experimental | Drug: anti-hypertensive medicationcommunity dwelling hypertensive elderly from general practices |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age >= 70 years
- Systolic office blood pressure >= 160 mmHg
- Systolic home blood pressure >= 155 mmHg
Key exclusion criteria (8 listed)
- Diabetes Mellitus
- Atrial fibrillation
- Dementia
- Renal failure requiring dialysis
- Life expectancy of less than 1 year
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 medication8-12 weeks of anti-hypertensive treatment with 2 weekly titration using registered hypertensive medication | Drug | Hypertensive elderly |
Primary outcome
Cerebral blood flow
Time frame: T1, 8-12 weeks of treatment, T2
1 secondary outcome
Cognitive functioning assessed by neuropsychological testing
Time frame: T1, 8-12 weeks of treatment, T2-3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2009.
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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.
Jurgen A Claassen, 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 Phase 4 study testing anti-hypertensive medication 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 3 inclusion and 8 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 26 Aug 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jaap C Sijbesma, MD (0243616772 ext. +31, J.Sijbesma@ger.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: T1, 8-12 weeks of treatment, T2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2009.