Resistant HypertensionNCT02001350
Carotid Ultrasound Study
An observational study of Resistant Hypertension, run by Noblewell at 1 site in Poland.
Trial summary
To use carotid ultrasound to screen 20-30 patients with longstanding or resistant hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and will give insight into the prevalence and specific… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Ultrasonography
- How many people
- 23 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2013to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients with longstanding or resistant hypertension
Who may be able to join
- 18-75 years old
- Uncontrolled hypertension on 3 or more medications or longstanding controlled hypertension on 4 or more medications.
Who cannot join
- Previous stroke
- Carotid endarterectomy or carotid stent procedure
- >50% stenosis anywhere in carotid arteries
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Hypertension and Diabetology, Medical University of Gdansk
Gdansk, 80-952
About this study
To use carotid ultrasound to screen 20-30 patients with longstanding or resistant hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and will give insight into the prevalence and specific location of carotid plaque at the bifurcation in this patient population.
- Conditions
- Resistant Hypertension
- Being tested
- Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyOther
| Study group | Role | What they receive |
|---|---|---|
| Resistant hypertension | Not described Receives: Other: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific location of carotid plaque at the bifurcation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant 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
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noblewell
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cibiem, Inc.
- Responsible party
- Sponsor
- Investigators
- Paul A. Sobotka, MD, Study director, Cibiem, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001350
- Sponsor's protocol ID
- CIB-USG.GDA.PL
- Status last verified
- Oct 2016
- First submitted
- 22 Nov 2013
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Ultrasound Study
- ClinicalTrials.gov ID
- NCT02001350
- Acronym / sponsor ID
- CIB-USG.GDA.PL
- Conditions
- Resistant Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NoblewellIndustry (pharma, biotech, devices)
- Collaborators
- Cibiem, Inc.
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Dec 2013 (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.
To use carotid ultrasound to screen 20-30 patients with longstanding or resistant hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and will give insight into the prevalence and specific location of carotid plaque at the bifurcation in this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistant hypertension | – | Other: Ultrasonography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with longstanding or resistant hypertension
Key inclusion criteria (2 listed)
- 18-75 years old
- Uncontrolled hypertension on 3 or more medications or longstanding controlled hypertension on 4 or more medications.
Key exclusion criteria (3 listed)
- Previous stroke
- Carotid endarterectomy or carotid stent procedure
- >50% stenosis anywhere in carotid arteries
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 |
|---|---|---|
| Ultrasonography | Other | Resistant hypertension |
Primary outcome
Specific location of carotid plaque at the bifurcation
Time frame: Baseline
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 17 Oct 2016.
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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.
Paul A. Sobotka, MD study director
Cibiem, Inc.
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 Resistant Hypertension, run by Noblewell 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 2 inclusion and 3 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 17 Oct 2016. 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?
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?
Specific location of carotid plaque at the bifurcation (time frame: Baseline). 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 17 Oct 2016.