A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malignant Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- prognosis [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 36 centers
- CH d'Annecy — Annecy
- CH de la côte Basque — Bayonne
- Avicenne APHP — Bobigny
- CHU - Hôpital St André — Bordeaux
- CH de Chalon sur Saone — Chalon-sur-Saône
- CH Métropole — Chambéry
- CHU de Clermont FERRAND — Clermont-Ferrand
- Hôpital Henri Mondor — Créteil
- … and 28 more centers
Poland · 1 center
- National Institute of Cardiology — Warsaw
Publications
- Boulestreau R, Lorthioir A, Dreau H, Persu A, Cremer A, Tharaux PL, Rubin S, Maier B, Mazighi M, Seris A, Paques M, Bonnin S, Halimi JM, Debeugny S, Gosse P. Baseline characteristics of the first 302 patients included for acute malignant hypertension crisis in the prospective multidisciplinary HAMA cohort. J Hypertens. 2024 Dec 1;42(12):2131-2138. doi: 10.1097/HJH.0000000000003851. Epub 2024 Oct 7 PMID 39351849
Identifiers
NCT: NCT03755726 · CHPAU2018/01