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

May 23, 2017 updated by: PD Dr. Grégoire Wuerzner

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • Service of nephrology and hypertension
    • VD
      • Lausanne, VD, Switzerland, 1011
        • Service of nephrology and hypertension

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 in control group, obesisty group and white coat hypertension group
Active Comparator: 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 in control group, obesisty group and white coat hypertension group
Active Comparator: 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 in control group, obesisty group and white coat hypertension group
Active Comparator: Resistant hypertension
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)
Lower limbs are put in in LBNP device for one hour (-30 mbar)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
glomerular filtration rate
Time Frame: after one hour of lower body negative pressure
after one hour of lower body negative pressure

Other Outcome Measures

Outcome Measure
Time Frame
renal plasma flow
Time Frame: after one hour of lower body negative pressure
after one hour of lower body negative pressure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PD Dr. Grégoire Wuerzner

Collaborators

Swiss National Science Foundation

Investigators

  • Study Chair: Michel Burnier, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 21, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PZ00P3_121655

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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