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

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
PD Dr. Grégoire Wuerzner, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01734096
First received: November 21, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine whether in pre-hypertensive states such as white coat hypertension or obesity related hypertension, renal function is more sensitive to orthostatic stress.


Condition Intervention Phase
Hypertension
Obesity
White Coat Hypertension
Other: Lower body negative pressure (LBNP)
Drug: Candesartan cilexetil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • sodium excretion [ Time Frame: after one hour of lower body negative pressure ] [ Designated as safety issue: No ]
    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 [ Time Frame: after one hour of lower body negative pressure ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • renal plasma flow [ Time Frame: after one hour of lower body negative pressure ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2009
Study Completion Date: April 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > 30 Kg/m2 (obesity group)
  • office BP >140/90 and daytime ambulatory blood pressure <135/85 (white coat hypertension group)

Exclusion Criteria:

  • History of allergic reaction
  • Diabetes type 1 or type 2
  • History of renal artery stenosis
  • Acute illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734096

Locations
Switzerland
Service of nephrology and hypertension
Lausanne, VD, Switzerland, 1011
Service of nephrology and hypertension
Lausanne, Switzerland, 1011
Sponsors and Collaborators
PD Dr. Grégoire Wuerzner
Swiss National Science Foundation
Investigators
Principal Investigator: Gregoire Wuerzner, MD Centre Hospitalier Universitaire Vaudois
Study Chair: Michel Burnier, MD Centre Hospitalier Universitaire Vaudois
  More Information

No publications provided

Responsible Party: PD Dr. Grégoire Wuerzner, Doctord, MD, privat docent, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01734096     History of Changes
Other Study ID Numbers: PZ00P3_121655
Study First Received: November 21, 2012
Last Updated: August 12, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:
hypertension
obesity
white coat hypertension

Additional relevant MeSH terms:
Hypertension
Obesity
White Coat Hypertension
Body Weight
Cardiovascular Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Vascular Diseases
Candesartan
Candesartan cilexetil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014