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Post CVA Persistent Hypertension Caring (Hippocrate)

Primary Purpose

Post CVA Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Auto-measure of the tension by an autotensiometer
Auto-measure of the tension by an autotensiometer
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post CVA Hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • CH Bar Le DucRecruiting
  • CHU de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

tensional auto-measure

Secondary Outcome Measures

Full Information

First Posted
March 16, 2010
Last Updated
November 12, 2013
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT01109251
Brief Title
Post CVA Persistent Hypertension Caring
Acronym
Hippocrate
Official Title
Post CVA Persistent Hypetension, Interest of Caring by Tensional Auto-measures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post CVA Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Other
Arm Description
Group of patients presenting a non controlled AHT or a masked AHT, benefiting from an optimised caring at visit 0.
Arm Title
Control group
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Auto-measure of the tension by an autotensiometer
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Auto-measure of the tension by an autotensiometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
tensional auto-measure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Facility Information:
Facility Name
CH Bar Le Duc
City
Bar Le Duc
ZIP/Postal Code
55000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien RICHARD, MD
Phone
3 83 15 96 82
Ext
+33
Email
s.richard@chu-nancy.fr
Facility Name
CHU de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc BOIVIN, MD,
Phone
3 83 15 73 11
Ext
+33
Email
jm.boivin@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Sanae BOUALI, PhD
Phone
3 83 15 74 38
Ext
+33
Email
s.bouali@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Xavier DUCROCQ, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jean-Marc BOIVIN
First Name & Middle Initial & Last Name & Degree
Patrick ROSSIGNOL
First Name & Middle Initial & Last Name & Degree
Sebastien LEFEVRE
First Name & Middle Initial & Last Name & Degree
Sébastien RICHARD
First Name & Middle Initial & Last Name & Degree
Karine LAVANDIER

12. IPD Sharing Statement

Learn more about this trial

Post CVA Persistent Hypertension Caring

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