A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort

Recruiting

• Conditions: Malignant Hypertension

• Registration Number: NCT03755726
• Lead Sponsor: Centre Hospitalier de PAU

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.

Study Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-28
• Study Start: 2019-09-20
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-27
• Primary Completion: 2034-09-20
• Study Completion: 2034-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prognosis	5 years	5-year prognosis for patients with malignant hypertension

Trial Locations

Locations (37)

CH Métropole; 🇫🇷 Chambéry, France

National Institute of Cardiology; 🇵🇱 Varsovia, Poland

CH de la côte Basque; 🇫🇷 Bayonne, France

CH d'Annecy; 🇫🇷 Annecy, France

Avicenne APHP; 🇫🇷 Bobigny, France

CHU - Hôpital St André; 🇫🇷 Bordeaux, France

CH de Chalon sur Saone; 🇫🇷 Chalon-sur-Saône, France

CHU de Clermont FERRAND; 🇫🇷 Clermont-Ferrand, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CH de Dinard; 🇫🇷 Dinard, France

CHU Michallon; 🇫🇷 Grenoble, France

CHRU de Lille; 🇫🇷 Lille, France

hôpital de Haguenau; 🇫🇷 Haguenau, France

Pôle Santé Sud; 🇫🇷 Le Mans, France

CH de Libourne; 🇫🇷 Libourne, France

Clinique Vert Coteau; 🇫🇷 Marseille, France

Hopital de la conception; 🇫🇷 Marseille, France

CHU de Montellier; 🇫🇷 Montpellier, France

CHU - Hôpital Laennec; 🇫🇷 Nantes, France

CH Martigues; 🇫🇷 Martigues, France

Hôpital Saint Joseph; 🇫🇷 Paris, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

CHU de Pointe à Pitre; 🇫🇷 Pîtres, France

CHU de Rennes; 🇫🇷 Rennes, France

APHP Bichat; 🇫🇷 Paris, France

Fondation Adolphe de Rothschild; 🇫🇷 Paris, France

Hôpital Tenon; 🇫🇷 Paris, France

CH de PAU; 🇫🇷 PAU, France

CHU de ROUEN; 🇫🇷 Rouen, France

CHU de Poitiers; 🇫🇷 Poitiers, France

Clinique sainte Clotilde; 🇫🇷 Saint denis, France

CH de St Nazaire; 🇫🇷 Saint-Nazaire, France

CHU de St Etienne; 🇫🇷 Saint-Étienne, France

CHU de Toulouse Rangueil; 🇫🇷 Toulouse, France

CHU de Tours; 🇫🇷 Tours, France

CH de Valenciennes; 🇫🇷 Valenciennes, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France