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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734096
• Other study ID #: PZ00P3_121655
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2012
• Last updated: May 23, 2017
• Start date: May 2009
• Est. completion date: April 2016

Study information

• Verified date: May 2017
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2016
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Obesity
• Resistant Hypertension
• White Coat Hypertension

Intervention

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 in control group, obesisty group and white coat hypertension group

Locations

Country	Name	City	State
Switzerland	Service of nephrology and hypertension	Lausanne	VD
Switzerland	Service of nephrology and hypertension	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
PD Dr. Grégoire Wuerzner	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	renal plasma flow		after one hour of lower body negative pressure
Primary	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	glomerular filtration rate		after one hour of lower body negative pressure