Post CVA HypertensionHippocrateNCT01109251
Post CVA Persistent Hypertension Caring
A study testing Auto-measure of the tension by an autotensiometer in people with Post CVA Hypertension, run by Central Hospital, Nancy, France at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Post CVA Hypertension
- What is being tested?
- Auto-measure of the tension by an autotensiometer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2011to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CH Bar Le Duc
Bar-le-Duc, 55000
Sébastien RICHARD, MD, 3 83 15 96 82 ext. +33, s.richard@chu-nancy.fr
- Recruiting
CHU de Nancy
Nancy, France, 54000
Jean-Marc BOIVIN, MD,, 3 83 15 73 11 ext. +33, jm.boivin@chu-nancy.fr
Sanae BOUALI, PhD, 3 83 15 74 38 ext. +33, s.bouali@chu-nancy.fr
About this study
Official title: Post CVA Persistent Hypetension, Interest of Caring by Tensional Auto-measures
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.
- Conditions
- Post CVA Hypertension
- Being tested
- Auto-measure of the tension by an autotensiometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-measure of the tension by an autotensiometerProcedure or surgery
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.
Auto-measure of the tension by an autotensiometerProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Group of patients presenting a non controlled AHT or a masked AHT, benefiting from an optimised caring at visit 0. Receives: Procedure: Auto-measure of the tension by an autotensiometer |
| Control group | Other | 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 Receives: Procedure: Auto-measure of the tension by an autotensiometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
tensional auto-measure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startJul 2011
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post CVA HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109251
- Sponsor's protocol ID
- Hippocrate
- Acronym
- Hippocrate
- Status last verified
- Nov 2013
- First submitted
- 16 Mar 2010
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post CVA Persistent Hypetension, Interest of Caring by Tensional Auto-measures
- ClinicalTrials.gov ID
- NCT01109251
- Acronym / sponsor ID
- Hippocrate / Hippocrate
- Conditions
- Post CVA Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Procedure: Auto-measure of the tension by an autotensiometerGroup of patients presenting a non controlled AHT or a masked AHT, benefiting from an optimised caring at visit 0. |
| Control group | Other | Procedure: Auto-measure of the tension by an autotensiometerPatients 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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 :
- Severe concomitant Pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-measure of the tension by an autotensiometerAll 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. | Procedure or surgery | Intervention group |
| Auto-measure of the tension by an autotensiometerAll 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. | Procedure or surgery | Control group |
Primary outcome
tensional auto-measure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-measure of the tension by an autotensiometer in people with Post CVA Hypertension, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tensional auto-measure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.