HypertensionNCT01837784
Central Hemodynamics
An observational study of Hypertension, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
Guidelines recommend measuring end organ damage and in particular arterial stiffness in patients with hypertension. However, until now it was not possible to measure arterial stiffness with the use of simple methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Optimization of blood pressure according to guidelines
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2013to Mar 2016
- 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 referred for optimization of antihypertensive treatment to Luzerner Kantonsspital, Switzerland.
Who may be able to join
- Patients >70 years (elderly cohort)
- Patients with diabetes mellitus (diabetes cohort)
- Patients with heart failure (heart failure cohort)
- Patients with resistant hypertension (resistant hypertension cohort)
Who cannot join
- Patient refuses study participation
- Severe renal failure
- Reduced life expectancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Kantonsspital
Lucerne, Canton of Lucerne, CH-6000
Paul Erne, MD, ++41 41 205 5208, paul.erne@luks.ch
Renate Schoenenberger, MD
About this study
Official title: Value of Non-invasively Measured Arterial Stiffness and Central Hemodynamics for Guiding Antihypertensive Treatment in Selected Patient Populations
Guidelines recommend measuring end organ damage and in particular arterial stiffness in patients with hypertension. However, until now it was not possible to measure arterial stiffness with the use of simple methods. Recently, novel and innovative devices offering determination of arterial stiffness and central hemodynamics from simple and non-invasive arm cuff measurements have now become available. This study therefore evaluates the value of non-invasively measured arterial stiffness and central hemodynamics for guiding antihypertensive treatment in selected patient populations (i.e. elderly patients, patients with diabetes mellitus, patients with heart failure, and patients with resistant hypertension).
- Conditions
- Hypertension
- Being tested
- Optimization of blood pressure according to guidelines
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization of blood pressure according to guidelinesOther
There is no specific recommendation for the intervention. The goal of the intervention is an optimization of blood pressure control. The intervention is at the discretion of the physician, but should adhere to guidelines. The intervention may therefore embrace measures such as drug prescriptions or lifestyle interventions.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients | Not described Receives: Other: Optimization of blood pressure according to guidelines | |
| Patients with diabetes mellitus | Not described Receives: Other: Optimization of blood pressure according to guidelines | |
| Patients with heart failure | Not described Receives: Other: Optimization of blood pressure according to guidelines | |
| Patients with resistant hypertension | Not described Receives: Other: Optimization of blood pressure according to guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness and central hemodynamics
Non-invasive measurement of arterial stiffness and central hemodynamics with the Tensiomed Arteriograph device
Measured: 3 months
Cognitive function
Measurement with Mini Mental State Exam and Verbal Recall Test
Measured: 3 months
Secondary outcomes (3)
Physical function
Measurement with gait speed, hand grip test and physical activity questionnaire
Measured: 3 months
Orthostatic hypotension and falls
Measurement with blood pressure recordings and structured questionnaire
Measured: 3 months
Renal failure
Creatinine measurement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2016 (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.
- 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
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Paul Erne, Luzerner Kantonsspital
- Investigators
- Paul Erne, MD, Study chair, Luzerner KantonsspitalPaul Erne, MD, Principal investigator, Luzerner KantonsspitalAndreas W Schoenenberger, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837784
- Sponsor's protocol ID
- 13024
- Status last verified
- Apr 2013
- First submitted
- 16 Apr 2013
- Last updated
- 23 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Non-invasively Measured Arterial Stiffness and Central Hemodynamics for Guiding Antihypertensive Treatment in Selected Patient Populations
- ClinicalTrials.gov ID
- NCT01837784
- Acronym / sponsor ID
- 13024
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (estimated)
- First posted
- 23 Apr 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.
Guidelines recommend measuring end organ damage and in particular arterial stiffness in patients with hypertension. However, until now it was not possible to measure arterial stiffness with the use of simple methods. Recently, novel and innovative devices offering determination of arterial stiffness and central hemodynamics from simple and non-invasive arm cuff measurements have now become available. This study therefore evaluates the value of non-invasively measured arterial stiffness and central hemodynamics for guiding antihypertensive treatment in selected patient populations (i.e. elderly patients, patients with diabetes mellitus, patients with heart failure, and patients with resistant hypertension).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Elderly patients | – | Other: Optimization of blood pressure according to guidelines |
| Patients with diabetes mellitus | – | Other: Optimization of blood pressure according to guidelines |
| Patients with heart failure | – | Other: Optimization of blood pressure according to guidelines |
| Patients with resistant hypertension | – | Other: Optimization of blood pressure according to guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for optimization of antihypertensive treatment to Luzerner Kantonsspital, Switzerland.
Key inclusion criteria (4 listed)
- Patients >70 years (elderly cohort)
- Patients with diabetes mellitus (diabetes cohort)
- Patients with heart failure (heart failure cohort)
- Patients with resistant hypertension (resistant hypertension cohort)
Key exclusion criteria (3 listed)
- Patient refuses study participation
- Severe renal failure
- Reduced life expectancy
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 |
|---|---|---|
| Optimization of blood pressure according to guidelinesThere is no specific recommendation for the intervention. The goal of the intervention is an optimization of blood pressure control. The intervention is at the discretion of the physician, but should adhere to guidelines. The intervention may therefore embrace measures such as drug prescriptions or lifestyle interventions. | Other | Elderly patients, Patients with diabetes mellitus, Patients with heart failure, Patients with resistant hypertension |
Primary outcome
Arterial stiffness and central hemodynamics
Time frame: 3 months
Non-invasive measurement of arterial stiffness and central hemodynamics with the Tensiomed Arteriograph device
Cognitive function
Time frame: 3 months
Measurement with Mini Mental State Exam and Verbal Recall Test
3 secondary outcomes
Physical function
Time frame: 3 months
Orthostatic hypotension and falls
Time frame: 3 months
Renal failure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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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 Erne, MD study chair
Luzerner Kantonsspital
Paul Erne, MD principal investigator
Luzerner Kantonsspital
Andreas W Schoenenberger, MD principal investigator
University of Bern
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 Luzerner Kantonsspital at 1 site in Switzerland.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Apr 2013. 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 Switzerland. 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 Paul Erne, MD (++41 41 205 5208, paul.erne@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness and central hemodynamics (time frame: 3 months). The study lists 2 primary outcomes in all. 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 23 Apr 2013.