Malignant HypertensionHAMANCT03755726
A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort
An observational study of Malignant Hypertension, run by Centre Hospitalier de PAU at 37 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hypertension
- How many people
- 1,200 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 20 Sep 2019to 20 Sep 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with malignant hypertension
Who may be able to join
- 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
Who cannot join
- Age < 18 years old
- Patients who cannot freely give their consent, or patients who refuse to participate
- Dialysis
Trial locations and contacts
37 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 2 countries
France36 sites, 36 recruiting
- Recruiting
CH d'Annecy
Annecy
Sandra JOST TURILLOT, 04 50 63 65 22, sjostturrillot@ch-annecygenevois.fr
- Recruiting
CH de la côte Basque
Bayonne, 64109
Adeline Marie LACRAZ, 05 59 44 38 64, alacraz@ch-cotebasque.fr
- Recruiting
Avicenne APHP
Bobigny, 93009
Marilucy LOPEZ SUBLET, 01 48 95 53 91, marilucy.lopez-sublet@aphp.fr
- Recruiting
CHU - Hôpital St André
Bordeaux, 33000
Philippe GOSSE, 05 56 79 58 89, philippe.gosse@chu-bordeaux.fr
- Recruiting
CH de Chalon sur Saone
Chalon-sur-Saône
Maxime FAYARD, 03 85 91 00 22, Maxime.Fayard@ch-chalon71.fr
- Recruiting
CH Métropole
Chambéry, 73011
Stéphane BALLY, 04 79 96 50 84, stephane.bally@ch-metropole-savoie.fr
- Recruiting
CHU de Clermont FERRAND
Clermont-Ferrand
Carole Philipponne, 04 73 75 14 25, cphilipponnet@chu-clermontferrand.fr
- Recruiting
Hôpital Henri Mondor
Créteil
Khalil El KAROUI, 01 49 81 44 15, khalil.el-karoui@inserm.fr
- Recruiting
CH de Dinard
Dinard, 35800
Thierry DENOLLE, 02 99 46 75 17, denolle.thierry@wanadoo.fr
- Recruiting
CHU Michallon
Grenoble, 38043
Olivier ORMEZZANO, 04 76 76 54 37, OOrmezzano@chu-grenoble.fr
- Recruiting
hôpital de Haguenau
Haguenau, 67504
Yves DIMITROV, 03 88 06 33 30, yves.dimitrov@ch-haguenau.fr
- Recruiting
Pôle Santé Sud
Le Mans
Christophe BACHELET, 02 43 78 45 90, christophe.bachelet@me.com
- Recruiting
CH de Libourne
Libourne, 33505
Adrien KELLER, 05 57 55 34 62, adrien.keller@ch-libourne.fr
- Recruiting
CHRU de Lille
Lille, 59037
Pascal DELSART, 03 20 44 54 63, Pascal.DELSART@chru-lille.fr
- Recruiting
Clinique Vert Coteau
Marseille, 13012
Michèle ESCANDE, 04 91 18 65 33, micheleescande@hotmail.com
- Recruiting
Hopital de la conception
Marseille, 13385
Thomas ROBERT, 04 91 38 30 42, Thomas.ROBERT@ap-hm.fr
- Recruiting
CH Martigues
Martigues, 13500
Christophe BOUAKA, 04 42 43 22 22, Christophe.BOUAKA@ch-martigues.fr
- Recruiting
CHU de Montellier
Montpellier
Pierre FESLER, 04 67 33 84 43, p-fesler@chu-montpellier.fr
- Recruiting
CHU - Hôpital Laennec
Nantes, 44800
Guillaume LAMIRAULT, 02 40 08 23 43, guillaume.lamirault@chu-nantes.fr
- Recruiting
Hôpital Saint Joseph
Paris, 75014
Yara HANON - ANTAKLY, 01 44 12 79 13, YAntakly@hpsj.fr
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Aurélien LORTHIOIR, 01 56 09 37 76, aurelien.lorthioir@aphp.fr
- Recruiting
APHP Bichat
Paris, 75877
Emmenuelle VIDAL PETIOT, 01 40 25 84 69, emmanuelle.vidal-petiot@aphp.fr
- Recruiting
Fondation Adolphe de Rothschild
Paris
Benjamin MAIER, 01 48 03 65 65, benjamin.maier025@gmail.com
- Recruiting
Hôpital Tenon
Paris
Laurent MESNARD, 01 56 01 65 02, laurent.mesnard@aphp.fr
- Recruiting
CH de PAU
Pau, 64000
Romain Boustreau, 05 59 92 48 83, romain.boulestreau@ch-pau.fr
- Not yet recruiting
CHU de Pointe à Pitre
Pitres, 97159
Valérie ALOPH GALANTINE, 05 90 89 13 27, valerie.aloph@chu-guadeloupe.fr
- Recruiting
CHU de Poitiers
Poitiers, 86021
Benoit LEQUEUX, 05 49 44 44 44, Benoit.LEQUEUX@chu-poitiers.fr
- Recruiting
CHU de Rennes
Rennes, 35033
Caroline DOURMAP, 02 99 28 25 08, caroline.dourmap-collas@chu-rennes.fr
- Recruiting
CHU de ROUEN
Rouen, 76000
Dominique GUERROT, 02 32 88 90 15, Dominique.Guerrot@chu-rouen.fr
- Recruiting
Clinique sainte Clotilde
Saint-Denis, 97400
Lucas MORLON, 02 62 48 20 20, lucasmorlon@gmail.com
- Recruiting
CHU de St Etienne
Saint-Etienne, 42055
Miriana DINIC, 04 77 82 83 80, miriana.dinic@chu-st-etienne.fr
- Recruiting
CH de St Nazaire
Saint-Nazaire, 44606
Sylvie LE COZ, 02 72 27 82 72, s.regnier-lecoz@ch-saintnazaire.fr
- Recruiting
CHU de Strasbourg
Strasbourg, 67000
Dominique STEPHAN, 03.69.55.05.83, Dominique.stephan@chru-strasbourg.fr
- Recruiting
CHU de Toulouse Rangueil
Toulouse, 31059
Béatrice DULY-BOUHANICK, 05-61-32-21-59, duly-bouhanick.b@chu-toulouse.fr
- Recruiting
CHU de Tours
Tours, 37044
Jean Michel HALIMI, 02 47 47 37 46, halimi@med.univ-tours.fr
- Recruiting
CH de Valenciennes
Valenciennes
Claire CARTERY, 03 27 14 30 89, claire.cartery@dbmail.com
Poland1 site, 1 recruiting
- Not yet recruiting
National Institute of Cardiology
Warsaw
Andrzej Januszewicz, ajanu@op.pl
About this study
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.
Read the 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.
- Conditions
- Malignant Hypertension
- Medical subject headings
- Hypertension, Malignant
What is being measured
The primary outcome is the main question the study is designed to answer.
prognosis
5-year prognosis for patients with malignant hypertension
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start20 Sep 2019
- Primary completion20 Sep 2034 (estimated)
- Study completion20 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de PAU
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Boulestreau, Centre Hospitalier de PAU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755726
- Sponsor's protocol ID
- CHPAU2018/01
- Acronym
- HAMA
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2018
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39351849
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort
- ClinicalTrials.gov ID
- NCT03755726
- Acronym / sponsor ID
- HAMA / CHPAU2018/01
- Conditions
- Malignant Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Centre Hospitalier de PAUUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 20 Sep 2034 (estimated)
- Study completion
- 20 Sep 2034 (estimated)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant hypertension
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years old
- Patients who cannot freely give their consent, or patients who refuse to participate
- Dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prognosis
Time frame: 5 years
5-year prognosis for patients with malignant hypertension
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 39351849Boulestreau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Hypertension, run by Centre Hospitalier de PAU at 37 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.