- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01109251
Post CVA Persistent Hypertension Caring (Hippocrate)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Bar Le Duc, Frankrike, 55000
- Rekruttering
- CH Bar le Duc
-
Ta kontakt med:
- Sébastien RICHARD, MD
- Telefonnummer: +33 3 83 15 96 82
- E-post: s.richard@chu-nancy.fr
-
Nancy, Frankrike, 54000
- Rekruttering
- CHU de Nancy
-
Ta kontakt med:
- Jean-Marc BOIVIN, MD,
- Telefonnummer: +33 3 83 15 73 11
- E-post: jm.boivin@chu-nancy.fr
-
Ta kontakt med:
- Sanae BOUALI, PhD
- Telefonnummer: +33 3 83 15 74 38
- E-post: s.bouali@chu-nancy.fr
-
Underetterforsker:
- Xavier DUCROCQ, MD, PhD
-
Hovedetterforsker:
- Jean-Marc BOIVIN
-
Underetterforsker:
- Patrick ROSSIGNOL
-
Underetterforsker:
- Sebastien LEFEVRE
-
Underetterforsker:
- Sébastien RICHARD
-
Underetterforsker:
- Karine LAVANDIER
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Intervention group
Group of patients presenting a non controlled AHT or a masked AHT, benefiting from an optimised caring at visit 0.
|
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. |
Annen: 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
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
tensional auto-measure
Tidsramme: 6 months
|
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Hippocrate
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Post CVA Hypertension
-
University Hospital of CologneUkjentNAFLD; Hypertensjon, White-Coat Hypertension, Masked HypertensionTyskland
-
Rambam Health Care CampusRekruttering
-
Karolinska InstitutetFullførtWhite Coat Hypertension
-
Clinical Hospital Centre ZagrebEuropean Society of HypertensionUkjentWhite Coat Hypertension | Blodtrykk | LivsstilsrisikoreduksjonIsrael, Hellas, Belgia, Tyskland, Armenia, Østerrike, Bulgaria, Kroatia, Tsjekkia, Estland, Italia, Libanon, Litauen, Nederland, Polen, Portugal, Romania, Serbia, Spania, Sverige, Ukraina, Storbritannia
-
Regional Hospital HolstebroFullførtSunn | White Coat Hypertension | Essensiell hypertensjonDanmark
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Aktiv, ikke rekrutterendeWhite Coat Hypertension | Hypertensjon, viktigForente stater
-
Centre Hospitalier Universitaire DijonFullførtSymptomatisk CVA (de Novo CVA)Frankrike
-
University of Alabama at BirminghamTroy UniversityFullførtHypertensjon | Hypertensjon, motstandsdyktig mot konvensjonell terapi | Ukontrollert hypertensjon | Hypertensjon, hvit pelsForente stater
-
Centre Hospitalier Universitaire DijonRekruttering
-
Sheba Medical CenterTel Aviv UniversityUkjent