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Completed

NCT Number: NCT01734096

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

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.

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Key information

Conditions

Hypertension Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Resistant Hypertension Signs and Symptoms Vascular Diseases White Coat Hypertension

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service of nephrology and hypertension, Lausanne, Canton of Vaud, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower body negative pressure (LBNP)

Other

Lower limbs are put in in LBNP device for one hour (-30 mbar)

Candesartan cilexetil

Drug

candesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group

Primary outcomes

  1. 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

Secondary outcomes

  1. glomerular filtration rate

    Time frame: after one hour of lower body negative pressure

Other outcomes

  1. renal plasma flow

    Time frame: after one hour of lower body negative pressure

Sponsors and collaborators

Lead sponsor

PD Dr. Grégoire Wuerzner

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2013
Study completion
2016
First posted
Nov 27, 2012
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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