Renal Response to Lower Body Negative Pressure in Pre-hypertensive States

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Hypertension, Obesity, White Coat Hypertension, Resistant Hypertension

Intervention / Treatment
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* Other: Lower body negative pressure (LBNP)
* Drug: Candesartan cilexetil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: History of allergic reaction Diabetes type 1 or type 2 History of renal artery stenosis Acute illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>healthy volunteer | Other: Lower body negative pressure (LBNP)<br>* Lower limbs are put in in LBNP device for one hour (-30 mbar)<br>Drug: Candesartan cilexetil<br>* candesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group<br>|
| Active Comparator: obesity group<br>Patients with BMI >30 Kg/m2 | Other: Lower body negative pressure (LBNP)<br>* Lower limbs are put in in LBNP device for one hour (-30 mbar)<br>Drug: Candesartan cilexetil<br>* candesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group<br>|
| Active Comparator: white coat hypertension group<br>Patients with office blood pressure >140/90 mmHg and ambulatory daytime blood pressure <135/85 mmHg | Other: Lower body negative pressure (LBNP)<br>* Lower limbs are put in in LBNP device for one hour (-30 mbar)<br>Drug: Candesartan cilexetil<br>* candesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group<br>|
| Active Comparator: Resistant hypertension<br>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. | Other: Lower body negative pressure (LBNP)<br>* Lower limbs are put in in LBNP device for one hour (-30 mbar)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | after one hour of lower body negative pressure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glomerular filtration rate |  | after one hour of lower body negative pressure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, obesity, white coat hypertension, resistant hypertension