Renal Response to Lower Body Negative Pressure in Pre-hypertensive States
This study is currently recruiting participants.
Verified November 2012 by Centre Hospitalier Universitaire Vaudois
Sponsor:
PD Dr. Grégoire Wuerzner
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
PD Dr. Grégoire Wuerzner, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01734096
First received: November 21, 2012
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to determine whether in pre-hypertensive states such as white coat hypertension or obesity related hypertension, renal function is more sensitive to orthostatic stress.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Obesity White Coat Hypertension |
Other: Lower body negative pressure (LBNP) Drug: Candesartan cilexetil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| 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. |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire Vaudois:
Primary Outcome Measures:
- sodium excretion [ Time Frame: after one hour of lower body negative pressure ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- glomerular filtration rate [ Time Frame: after one hour of lower body negative pressure ] [ Designated as safety issue: No ]
Other Outcome Measures:
- renal plasma flow [ Time Frame: after one hour of lower body negative pressure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
control group
healthy volunteer
|
Other: Lower body negative pressure (LBNP)
Lower limbs are put in in LBNP device for one hour (-30 mbar)
Drug: Candesartan cilexetil
candesartan cilexetil 16 mg once a day for 7 days cross over with placebo
|
|
obesity group
Patients with BMI >30 Kg/m2
|
Other: Lower body negative pressure (LBNP)
Lower limbs are put in in LBNP device for one hour (-30 mbar)
Drug: Candesartan cilexetil
candesartan cilexetil 16 mg once a day for 7 days cross over with placebo
|
|
white coat hypertension group
Patients with office blood pressure >140/90 mmHg and ambulatory daytime blood pressure <135/85 mmHg
|
Other: Lower body negative pressure (LBNP)
Lower limbs are put in in LBNP device for one hour (-30 mbar)
Drug: Candesartan cilexetil
candesartan cilexetil 16 mg once a day for 7 days cross over with placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- BMI > 30 Kg/m2 (obesity group)
- office BP >140/90 and daytime ambulatory blood pressure <135/85 (white coat hypertension group)
Exclusion Criteria:
- History of allergic reaction
- Diabetes type 1 or type 2
- History of renal artery stenosis
- Acute illness
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734096
Contacts
| Contact: Gregoire Wuerzner, MD | 0041 79 5561973 | gregoire.wuerzner@chuv.ch |
Locations
| Switzerland | |
| Service of nephrology and hypertension | Recruiting |
| Lausanne, VD, Switzerland, 1011 | |
| Contact: Gregoire Wuerzner, MD 0041 79 5561973 gregoire.wuerzner@chuv.ch | |
| Principal Investigator: Gregoire Wuerzner, MD | |
| Sub-Investigator: Michel Burnier, MD | |
| Service of nephrology and hypertension | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Grégoire Wuerzner, MD 0041 79 556 1973 gregoire.wuerzner@chuv.ch | |
| Contact: Michel Burnier 0041 21 3141129 michel.burnier@chuv.ch | |
| Principal Investigator: Gregoire Wuerzner, MD | |
| Sub-Investigator: Michel Burnier, MD | |
Sponsors and Collaborators
PD Dr. Grégoire Wuerzner
Swiss National Science Foundation
More Information
No publications provided
| Responsible Party: | PD Dr. Grégoire Wuerzner, Doctord, MD, privat docent, Centre Hospitalier Universitaire Vaudois |
| ClinicalTrials.gov Identifier: | NCT01734096 History of Changes |
| Other Study ID Numbers: | PZ00P3_121655 |
| Study First Received: | November 21, 2012 |
| Last Updated: | November 26, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Centre Hospitalier Universitaire Vaudois:
|
hypertension obesity white coat hypertension |
Additional relevant MeSH terms:
|
Hypertension Obesity Vascular Diseases Cardiovascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
Candesartan cilexetil Candesartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013