HypertensionPhase 4NCT01734096
Renal Response to Lower Body Negative Pressure in Pre-hypertensive States
A Phase 4 study testing Lower body negative pressure (LBNP) and Candesartan cilexetil in people with Hypertension and Obesity, run by PD Dr. Grégoire Wuerzner at 2 sites in Switzerland.
Trial summary
The purpose of this study is to determine whether in pre-hypertensive and hypertensive states such as white coat hypertension, obesity related hypertension or resistant hypertension, renal function is more sensitive to orthostatic stress. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Obesity, White Coat Hypertension
- What is being tested?
- Lower body negative pressure (LBNP) and Candesartan cilexetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesSwitzerland
- Study dates
- May 2009to Apr 2016
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > 30 Kg/m2 (obesity group)
- office BP >140/90 and daytime ambulatory blood pressure <135/85 (white coat hypertension group) _daytime abpm >135/85 mm Hg or nighttime abpm 120/70
Who cannot join
- History of allergic reaction
- Diabetes type 1 or type 2
- History of renal artery stenosis
- Acute illness
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Service of nephrology and hypertension
Lausanne, Canton of Vaud, 1011
Service of nephrology and hypertension
Lausanne, 1011
About this study
Official title: Effect of Lower Body Negative Pressure and Angiotensin II Receptor Blockade on Renal Hemodynamic, Neuro-hormonal and Tubular Response in Pre-hypertensive States: a Randomized Controlled Trial.
The purpose of this study is to determine whether in pre-hypertensive and hypertensive states such as white coat hypertension, obesity related hypertension or resistant hypertension, renal function is more sensitive to orthostatic stress.
- Conditions
- Hypertension, Obesity, White Coat Hypertension, Resistant Hypertension
- Being tested
- Lower body negative pressure (LBNP), Candesartan cilexetil
- Keywords
- hypertension, obesity, white coat hypertension, resistant hypertension
- Medical subject headings
- Hypertension, Obesity, White Coat Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower body negative pressure (LBNP)Other
Lower limbs are put in in LBNP device for one hour (-30 mbar)
Candesartan cilexetilDrug
candesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | healthy volunteer Receives: Other: Lower body negative pressure (LBNP); Drug: Candesartan cilexetil |
| obesity group | Active comparator | Patients with BMI >30 Kg/m2 Receives: Other: Lower body negative pressure (LBNP); Drug: Candesartan cilexetil |
| white coat hypertension group | Active comparator | Patients with office blood pressure >140/90 mmHg and ambulatory daytime blood pressure <135/85 mmHg Receives: Other: Lower body negative pressure (LBNP); Drug: Candesartan cilexetil |
| Resistant hypertension | Active comparator | Patients with ambulatory blood pressure > 135/85 mm Hg (day) or >120/70 mm Hg (night) with 3 antihypertensive drugs with direct observance of drug taking. Receives: Other: Lower body negative pressure (LBNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
sodium excretion
sodium excretion will be compared to control group (healthy volunteers) after one hour of lower negative pressure. The protocol includes 2 hours of baseline measure, one hour of lower negative pressure and 2 hours of recovery
Measured: after one hour of lower body negative pressure
Secondary outcomes (1)
glomerular filtration rate
Measured: after one hour of lower body negative pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startMay 2009
- Primary completionApr 2013
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- PD Dr. Grégoire Wuerzner
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor-investigator, PD Dr. Grégoire Wuerzner, Centre Hospitalier Universitaire Vaudois
- Investigators
- Gregoire Wuerzner, MD, Principal investigator, Centre Hospitalier Universitaire VaudoisMichel Burnier, MD, Study chair, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734096
- Sponsor's protocol ID
- PZ00P3_121655
- Status last verified
- May 2017
- First submitted
- 21 Nov 2012
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Vakilzadeh N, Petrovic D, Maillard M, Favre L, Grouzmann E, Wuerzner G. Impact of obesity with or without hypertension on systemic haemodynamic and renal responses to lower body negative pressure. Blood Press. 2021 Feb;30(1):67-74. doi: 10.1080/08037051.2020.1829963. Epub 2020 Oct 19.
PubMed 33073631Vuignier Y, Grouzmann E, Muller O, Vakilzadeh N, Faouzi M, Maillard MP, Qanadli SD, Burnier M, Wuerzner G. Blood Pressure and Renal Responses to Orthostatic Stress Before and After Radiofrequency Renal Denervation in Patients with Resistant Hypertension. Front Cardiovasc Med. 2018 May 23;5:42. doi: 10.3389/fcvm.2018.00042. eCollection 2018.
PubMed 29876358
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Body Negative Pressure and Angiotensin II Receptor Blockade on Renal Hemodynamic, Neuro-hormonal and Tubular Response in Pre-hypertensive States: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01734096
- Acronym / sponsor ID
- PZ00P3_121655
- Conditions
- Hypertension, Obesity, White Coat Hypertension, Resistant Hypertension
- Keywords
- hypertension, obesity, white coat hypertension, resistant hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- PD Dr. Grégoire WuerznerUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- May 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Nov 2012 (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 whether in pre-hypertensive and hypertensive states such as white coat hypertension, obesity related hypertension or resistant hypertension, renal function is more sensitive to orthostatic stress.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Lower body negative pressure (LBNP), Drug: Candesartan cilexetilhealthy volunteer |
| obesity group | Active comparator | Other: Lower body negative pressure (LBNP), Drug: Candesartan cilexetilPatients with BMI >30 Kg/m2 |
| white coat hypertension group | Active comparator | Other: Lower body negative pressure (LBNP), Drug: Candesartan cilexetilPatients with office blood pressure >140/90 mmHg and ambulatory daytime blood pressure <135/85 mmHg |
| Resistant hypertension | Active comparator | Other: Lower body negative pressure (LBNP)Patients with ambulatory blood pressure > 135/85 mm Hg (day) or >120/70 mm Hg (night) with 3 antihypertensive drugs with direct observance of drug taking. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 30 Kg/m2 (obesity group)
- office BP >140/90 and daytime ambulatory blood pressure <135/85 (white coat hypertension group) _daytime abpm >135/85 mm Hg or nighttime abpm 120/70
Key exclusion criteria (4 listed)
- History of allergic reaction
- Diabetes type 1 or type 2
- History of renal artery stenosis
- Acute illness
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 |
|---|---|---|
| Lower body negative pressure (LBNP)Lower limbs are put in in LBNP device for one hour (-30 mbar) | Other | Resistant hypertension, control group, obesity group, white coat hypertension group |
| Candesartan cilexetilcandesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group | Drug | control group, obesity group, white coat hypertension group |
Primary outcome
sodium excretion
Time frame: after one hour of lower body negative pressure
sodium excretion will be compared to control group (healthy volunteers) after one hour of lower negative pressure. The protocol includes 2 hours of baseline measure, one hour of lower negative pressure and 2 hours of recovery
1 secondary outcome
glomerular filtration rate
Time frame: after one hour of lower body negative pressure
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 24 May 2017.
- Derived from this study: PubMed 33073631Vakilzadeh N, Petrovic D, Maillard M, Favre L, Grouzmann E, Wuerzner G. Impact of obesity with or without hypertension on systemic haemodynamic and renal responses to lower body negative pressure. Blood Press. 2021 Feb;30(1):67-74. doi: 10.1080/08037051.2020.1829963. Epub 2020 Oct 19.
- Derived from this study: PubMed 29876358Vuignier Y, Grouzmann E, Muller O, Vakilzadeh N, Faouzi M, Maillard MP, Qanadli SD, Burnier M, Wuerzner G. Blood Pressure and Renal Responses to Orthostatic Stress Before and After Radiofrequency Renal Denervation in Patients with Resistant Hypertension. Front Cardiovasc Med. 2018 May 23;5:42. doi: 10.3389/fcvm.2018.00042. eCollection 2018.
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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.
Gregoire Wuerzner, MD principal investigator
Centre Hospitalier Universitaire Vaudois
Michel Burnier, MD study chair
Centre Hospitalier Universitaire Vaudois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lower body negative pressure (LBNP) and Candesartan cilexetil in people with Hypertension and Obesity, run by PD Dr. Grégoire Wuerzner at 2 sites 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 2 inclusion and 4 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
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?
sodium excretion (time frame: after one hour of lower body negative pressure). 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 NCT01734096, which also lists 2 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 24 May 2017.