Clinical trial NCT03755726: A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort
Official title: A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Hypertension
Lead sponsor: Centre Hospitalier de PAU
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with malignant hypertension

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: prognosis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH d'Annecy
city: Bayonne
country: France
facility: CH de la côte Basque
city: Bobigny
country: France
facility: Avicenne APHP
city: Bordeaux
country: France
facility: CHU - Hôpital St André
city: Chalon-sur-Saône
country: France
facility: CH de Chalon sur Saone
city: Chambéry
country: France
facility: CH Métropole
city: Clermont-Ferrand
country: France
facility: CHU de Clermont FERRAND
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dinard
country: France
facility: CH de Dinard
city: Grenoble
country: France
facility: CHU Michallon
city: Haguenau
country: France
facility: hôpital de Haguenau
city: Le Mans
country: France
facility: Pôle Santé Sud
city: Libourne
country: France
facility: CH de Libourne
city: Lille
country: France
facility: CHRU de Lille
city: Marseille
country: France
facility: Clinique Vert Coteau
city: Marseille
country: France
facility: Hopital de la conception
city: Martigues
country: France
facility: CH Martigues
city: Montpellier
country: France
facility: CHU de Montellier
city: Nantes
country: France
facility: CHU - Hôpital Laennec
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: APHP Bichat
city: Paris
country: France
facility: Fondation Adolphe de Rothschild
city: Paris
country: France
facility: Hôpital Tenon
city: PAU
country: France
facility: CH de PAU
city: Poitiers
country: France
facility: CHU de Poitiers
city: Pîtres
country: France
facility: CHU de Pointe à Pitre
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU de ROUEN
city: Saint denis
country: France
facility: Clinique sainte Clotilde
city: Saint-Nazaire
country: France
facility: CH de St Nazaire
city: Saint-Étienne
country: France
facility: CHU de St Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse Rangueil
city: Tours
country: France
facility: CHU de Tours
city: Valenciennes
country: France
facility: CH de Valenciennes
city: Varsovia
country: Poland
facility: National Institute of Cardiology
Study officials:
References: