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

Primary Purpose

Hypertension, Obesity, White Coat Hypertension

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Lower body negative pressure (LBNP)
Candesartan cilexetil
Sponsored by
PD Dr. Grégoire Wuerzner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring hypertension, obesity, white coat hypertension, resistant hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Service of nephrology and hypertension
  • Service of nephrology and hypertension

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

control group

obesity group

white coat hypertension group

Resistant hypertension

Arm Description

healthy volunteer

Patients with BMI >30 Kg/m2

Patients with office blood pressure >140/90 mmHg and ambulatory daytime blood pressure <135/85 mmHg

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

glomerular filtration rate

Full Information

First Posted
November 21, 2012
Last Updated
May 23, 2017
Sponsor
PD Dr. Grégoire Wuerzner
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01734096
Brief Title
Renal Response to Lower Body Negative Pressure in Pre-hypertensive States
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
PD Dr. Grégoire Wuerzner
Collaborators
Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Obesity, White Coat Hypertension, Resistant Hypertension
Keywords
hypertension, obesity, white coat hypertension, resistant hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
healthy volunteer
Arm Title
obesity group
Arm Type
Active Comparator
Arm Description
Patients with BMI >30 Kg/m2
Arm Title
white coat hypertension group
Arm Type
Active Comparator
Arm Description
Patients with office blood pressure >140/90 mmHg and ambulatory daytime blood pressure <135/85 mmHg
Arm Title
Resistant hypertension
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lower body negative pressure (LBNP)
Intervention Description
Lower limbs are put in in LBNP device for one hour (-30 mbar)
Intervention Type
Drug
Intervention Name(s)
Candesartan cilexetil
Intervention Description
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 Outcome Measure Information:
Title
sodium excretion
Description
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
Time Frame
after one hour of lower body negative pressure
Secondary Outcome Measure Information:
Title
glomerular filtration rate
Time Frame
after one hour of lower body negative pressure
Other Pre-specified Outcome Measures:
Title
renal plasma flow
Time Frame
after one hour of lower body negative pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregoire Wuerzner, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Burnier, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Study Chair
Facility Information:
Facility Name
Service of nephrology and hypertension
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Service of nephrology and hypertension
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33073631
Citation
Vakilzadeh N, Petrovic D, Maillard M, Favre L, Grouzmann E, Wuerzner G. Impact of obesity with or without hypertension on systemic haemodynamic and renal responses to lower body negative pressure. Blood Press. 2021 Feb;30(1):67-74. doi: 10.1080/08037051.2020.1829963. Epub 2020 Oct 19.
Results Reference
derived
PubMed Identifier
29876358
Citation
Vuignier Y, Grouzmann E, Muller O, Vakilzadeh N, Faouzi M, Maillard MP, Qanadli SD, Burnier M, Wuerzner G. Blood Pressure and Renal Responses to Orthostatic Stress Before and After Radiofrequency Renal Denervation in Patients with Resistant Hypertension. Front Cardiovasc Med. 2018 May 23;5:42. doi: 10.3389/fcvm.2018.00042. eCollection 2018.
Results Reference
derived

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

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