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Status unknownNCT01109251HippocrateUpdated Nov 13, 2013

Post CVA Persistent Hypertension Caring

An interventional study of Auto-measure of the tension by an autotensiometer and Auto-measure of the tension by an autotensiometer in Post CVA Hypertension, sponsored by Central Hospital, Nancy, France. Status unknown at 2 sites in France. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-11-13.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The study HIPPOCRATE is a prospective open comparative study with a control group.

The objective of this study is to show that an optimization of the caring of non controlled hypertended patients following a CVA (including a preliminary Tensional auto-measure (TAM) at the follow-up visit, an education of the patient with a decision support tree for the generalist and/or a visit in the multidisciplinary AHT department), allow to obtain a better tensional control copared to the usual caring.

Read the detailed description

This study compares the usual follow up of patients seen at a visit three months following the CVA, with a optimised follow up including the tensional auto-measure, the education of the patient and the information of the generalist and the appeal to the AHT multidisciplinary visit for resistant patients, in compliance with the guidelines.

All the hypertended patients able to realise a course of tensional automeasures will be invited to realise a course of tensional auto-measures during three days preceding the visit in the neurology department.

The tensional measures will be performed according the methodology recommended by HAS.

This strategy of caring is conform to the HAS and ESH recommendations regarding the follow up of the hypertended patients.

The hospitalised patients in neurology for CVA are in all cases convocated to the follow up visit three months after the hospitalisation. The patients will be trained in the use of the TAM by the nurse of the neurology depratment before his dropout from the neurology department at the end of hospitalisation.

The systematic use of TAM will allow to identify patients presenting a AHT "white blouse", but too patients presenting masked AHT.

The visit in the neurology department will be performed by the investigators of the neurology department. At the end of this visit, two groups of patients will be identified : patients with a controlled AHT (NI), and patients with a masked or non controlled AHT (MASC + NC).

Patients presenting a controlled AHT or a "white blouse" AHT (NI) will not be randomised. But it will be proposed to them to sign a consent to acquire their agreement to realise a exploitation of their data. This will allow to caracterise better this population of patients.

Patients presenting a masked or non controlled AHT will be invited to participate to the study after signing a consent.

The collection of the consent will be done by the investigators of the neurology department.

02

Conditions studied

  • Post CVA Hypertension
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 797 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient male or female from 20 to 80 years old included.

  • ischemic or haemorragic CVA or TIA necessiting an hospitalisation or a consultation in the neurolgy department, from more than 2 months.
  • Pression ≥140/90 ou 130/80 (diabetic) during the post CVA consultation and a mean TAM ≥135/85 ou 125/75 (diabetic) = non controlled AHT OR Pression \< 140/90 ou 130/80 (diabetic) during the post CVA consultation and a mean TAM ≥ 135/85 ou 125/75 (diabetic) = masked AHT
  • Patient agreed to participate to the study and having signed the informed consent from

Exclusion criteria

Exclusion Criteria:

  • malignant AHT necessiting the urgent and specialised caring
  • Persistance of a carotids bilateral stenosis from more than 70%
  • Severe Renal Insufficiency (Creatinin Clearance estimated by the formula MDRD \< 30 ml/mn)
  • CVA with major sequelae which according the judgement of the investigator will not allow to realise TAM :

    • Major Cognitive Troubles
    • Severe motor Troubles
  • Severe concomitant Pathology
  • Patient not speaking and not understanding french.
  • Contre-indications to the realisation of TAM :

    • Cardiac Arythmy
    • Obese Patients for which the circumference of the arm is > 33 cm
  • Patient refusing to go to the 3 months after hospitalisation follow up consultation.
  • Patient with no identified generalist
  • Patient refusing to sign the informed consent form.
  • Absence of affiliation to a Social system.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Other
    Intervention group

    Group of patients presenting a non controlled AHT or a masked AHT, benefiting from an optimised caring at visit 0.

    Procedure: Auto-measure of the tension by an autotensiometer

  • Other
    Control group

    Patients presenting a non controlled AHT(persistent AHT, AHT necessiting an adaptation of the treatment by the generalist) with information of the generalist on the necessity of obtaining the tensional control according the HAS recommendations

    Procedure: Auto-measure of the tension by an autotensiometer

Interventions

  • ProcedureAuto-measure of the tension by an autotensiometer

    All hypertended patients able to realise a serie of tensional auto-measures will be invited to realise a serie of tensional auto-measures theree days before the consultation in the neurology department. The auto-measures will be performed according the methodology recommended by HAS.

  • ProcedureAuto-measure of the tension by an autotensiometer

    All hypertended patients able to realise a serie of tensional auto-measures will be invited to realise a serie of tensional auto-measures theree days before the consultation in the neurology department. The auto-measures will be performed according the methodology recommended by HAS.

06

What researchers measure

Primary outcomes

  1. tensional auto-measure

    Time frame: 6 months

07

Study locations

2 of 2 sites recruiting
  • CHU de Nancy
    Nancy, France 54000, France
    • Jean-Marc BOIVIN, MD, · Contact · jm.boivin@chu-nancy.fr · 3 83 15 73 11
    • Sanae BOUALI, PhD · Contact · s.bouali@chu-nancy.fr · 3 83 15 74 38
    • Xavier DUCROCQ, MD, PhD · Sub investigator
    • Jean-Marc BOIVIN · Principal investigator
    • Patrick ROSSIGNOL · Sub investigator
    • Sebastien LEFEVRE · Sub investigator
    • Sébastien RICHARD · Sub investigator
    • Karine LAVANDIER · Sub investigator
    Recruiting
  • CH Bar Le Duc
    Bar-le-Duc, 55000, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01109251
Responsible party
Sponsor
First posted
Apr 23, 2010
Start date
Jul 2011
Primary completion
Jan 2015 (estimated)
Completion
Jan 2015 (estimated)
Last update
Nov 13, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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