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

Phase 4

Completed

• Conditions: White Coat Hypertension; Hypertension; Obesity; Resistant Hypertension
• Interventions: Other: Lower body negative pressure (LBNP); Drug: Candesartan cilexetil

• Registration Number: NCT01734096
• Lead Sponsor: PD Dr. Grégoire Wuerzner

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Primary Completion: 2013-04
• Study Completion: 2016-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
obesity group	Lower body negative pressure (LBNP)	Patients with BMI \>30 Kg/m2
Resistant hypertension	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.
white coat hypertension group	Lower body negative pressure (LBNP)	Patients with office blood pressure \>140/90 mmHg and ambulatory daytime blood pressure \<135/85 mmHg
control group	Lower body negative pressure (LBNP)	healthy volunteer
white coat hypertension group	Candesartan cilexetil	Patients with office blood pressure \>140/90 mmHg and ambulatory daytime blood pressure \<135/85 mmHg
control group	Candesartan cilexetil	healthy volunteer
obesity group	Candesartan cilexetil	Patients with BMI \>30 Kg/m2

Primary Outcome Measures

Name	Time	Method
sodium excretion	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

Secondary Outcome Measures

Name	Time	Method
glomerular filtration rate	after one hour of lower body negative pressure

Trial Locations

Locations (1)

Service of nephrology and hypertension; 🇨🇭 Lausanne, Switzerland