NCT01734096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started May 2009

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

3.9 years

First QC Date

November 21, 2012

Last Update Submit

May 23, 2017

Conditions

HypertensionObesityWhite Coat HypertensionResistant Hypertension

Keywords

hypertensionobesitywhite coat hypertensionresistant hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • glomerular filtration rate

    after one hour of lower body negative pressure

Other Outcomes (1)

  • renal plasma flow

    after one hour of lower body negative pressure

Study Arms (4)

control group

ACTIVE COMPARATOR

healthy volunteer

Other: Lower body negative pressure (LBNP)Drug: Candesartan cilexetil

obesity group

ACTIVE COMPARATOR

Patients with BMI \>30 Kg/m2

Other: Lower body negative pressure (LBNP)Drug: Candesartan cilexetil

white coat hypertension group

ACTIVE COMPARATOR

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

Other: Lower body negative pressure (LBNP)Drug: Candesartan cilexetil

Resistant hypertension

ACTIVE COMPARATOR

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)

Interventions

Lower body negative pressure (LBNP)OTHER

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

Resistant hypertensioncontrol groupobesity groupwhite coat hypertension group
Candesartan cilexetilDRUG

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

control groupobesity groupwhite coat hypertension group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of allergic reaction
  • Diabetes type 1 or type 2
  • History of renal artery stenosis
  • Acute illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service of nephrology and hypertension

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Service of nephrology and hypertension

Lausanne, 1011, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 33073631DERIVED

  • 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.

    PMID: 29876358DERIVED

MeSH Terms

Conditions

HypertensionObesityWhite Coat Hypertension

Interventions

Lower Body Negative Pressurecandesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DecompressionTherapeutics

Study Officials

  • Gregoire Wuerzner, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

  • Michel Burnier, MD

    Centre Hospitalier Universitaire Vaudois

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctord, MD, privat docent

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

May 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2016

Last Updated

May 24, 2017

Record last verified: 2017-05

Locations

CH(2)