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

NCT ID: NCT01734096

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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Hypertension Obesity White Coat Hypertension Resistant Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control group

healthy volunteer

Group Type ACTIVE_COMPARATOR

Lower body negative pressure (LBNP)

Intervention Type OTHER

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

Candesartan cilexetil

Intervention Type 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

obesity group

Patients with BMI \>30 Kg/m2

Group Type ACTIVE_COMPARATOR

Lower body negative pressure (LBNP)

Intervention Type OTHER

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

Candesartan cilexetil

Intervention Type 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

white coat hypertension group

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

Group Type ACTIVE_COMPARATOR

Lower body negative pressure (LBNP)

Intervention Type OTHER

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

Candesartan cilexetil

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Lower body negative pressure (LBNP)

Intervention Type OTHER

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

Interventions

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Lower body negative pressure (LBNP)

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

Intervention Type OTHER

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

PD Dr. Grégoire Wuerzner

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Grégoire Wuerzner

Doctord, MD, privat docent

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gregoire Wuerzner, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Michel Burnier, MD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Vaudois

Locations

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Service of nephrology and hypertension

Lausanne, Canton of Vaud, Switzerland

Site Status

Service of nephrology and hypertension

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 33073631 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29876358 (View on PubMed)

Other Identifiers

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PZ00P3_121655

Identifier Type: -

Identifier Source: org_study_id

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