Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03755726
Other study ID # CHPAU2018/01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 20, 2019
Est. completion date September 20, 2029

Study information

Verified date August 2022
Source Centre Hospitalier de PAU
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This registry aims to provide the first prospective, multicentric database of patients with malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity of current management and care pathway, to deepen our pathophysiological knowledges, to modernize the definition of this form of hypertension and its diagnostic criteria. The network that will emerge will finally lead to the opportunity of setting up therapeutic trials and establishing recommendations based on solid scientific evidence.


Description:

Malignant hypertension is the most severe form of high blood pressure, fatal if left untreated. It has not disappeared, with an increasing incidence. Patients with the disease, mainly young (35 to 55 years of age), have an unfavorable cardiovascular prognosis (14% of cardiovascular and renal events at 4 years). Despite these facts, scientific research on the subject remains limited. The definitions and diagnostic criteria have not changed since 1929, and the therapeutic recommendations remain empirical. This first prospective and multicentric registry will increase and modernize the knowledge of the disease. From these data, diagnostic and therapeutic recommendations based on solid scientific evidence could be developed. The investigators want to first recruit 500 patients and define their prognosis at 5 years. The impact of the patient's phenotype, type and number of target organs affected will be studied. A modern definition, adapted to these results, could be proposed. The epidemiology of the disease, the care pathways, the target organ disorders and the management carried out in the centers will be described in detail.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date September 20, 2029
Est. primary completion date September 20, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Malignant hypertension according to the classic definition (Severe hypertension, above 180/110 associated with severe hypertensive retinopathy) - Severe hypertension (above 180/110) associated with acute damage of 3 target organ due to high blood pressure Exclusion Criteria: - Age < 18 years old - Patients who cannot freely give their consent, or patients who refuse to participate - Dialysis

Study Design


Locations

Country Name City State
France CH d'Annecy Annecy
France CH de la côte Basque Bayonne
France Avicenne APHP Bobigny
France CHU - Hôpital St André Bordeaux
France CH de Chalon sur Saone Chalon-sur-Saône
France CH Métropole Chambéry
France CHU de Clermont FERRAND Clermont-Ferrand
France Hôpital Henri Mondor Créteil
France CH de Dinard Dinard
France CHU Michallon Grenoble
France hôpital de Haguenau Haguenau
France Pôle Santé Sud Le Mans
France CH de Libourne Libourne
France CHRU de Lille Lille
France Clinique Vert Coteau Marseille
France Hopital de la conception Marseille
France CH Martigues Martigues
France CHU de Montellier Montpellier
France CHU - Hôpital Laennec Nantes
France APHP Bichat Paris
France Fondation Adolphe de Rothschild Paris
France Hôpital Européen Georges Pompidou Paris
France Hôpital Saint Joseph Paris
France Hôpital Tenon Paris
France CH de PAU PAU
France CHU de Pointe à Pitre Pîtres
France CHU de Poitiers Poitiers
France CHU de Rennes Rennes
France CHU de ROUEN Rouen
France Clinique sainte Clotilde Saint denis
France CHU de St Etienne Saint-Étienne
France CH de St Nazaire Saint-Nazaire
France CHU de Strasbourg Strasbourg
France CHU de Toulouse Rangueil Toulouse
France CHU de Tours Tours
France CH de Valenciennes Valenciennes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier de PAU

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary prognosis 5-year prognosis for patients with malignant hypertension 5 years
See also
  Status Clinical Trial Phase
Completed NCT00616616 - Single Incision Laparoscopy N/A
Recruiting NCT04991077 - Interrupters of VAscular daMAge in Malignant Hypertension