Malignant HypertensionHAMABANKNCT06629363
Determinants of Malignant Hypertension Onset and Related Target Organ Damages: the HAMA Biobank
An observational study of Malignant Hypertension, run by Centre Hospitalier de PAU at 11 sites in France.
Trial summary
The HAMA bank is an initiative aimed at collecting, preparing, and storing biological samples from patients treated for malignant hypertension and included in the HAMA cohort. Conducted under CRB (ISO20387) conditions, this biobank serves as an essential resource for understanding the disease's pathophysiology, as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hypertension
- What is being tested?
- biobank
- How many people
- 1,000 participants
- Where
- 11 sitesFrance
- Study dates
- 19 Mar 2026to 1 Apr 2036
- 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
- patients included in the HAMA cohort with the following critera :
- Malignant hypertension according to the classic definition (Severe hypertension associated with severe hypertensive retinopathy)
- Severe hypertension associated with acute target organ damage due to high blood pressure
Who cannot join
- Refusal to participate to the substudy " HAMA bank "
- patient on chronic dialysis
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CH d'Annecy
Annecy
Sandra JOST TURILLOT, 04 50 63 65 22, sjostturrillot@ch-annecygenevois.fr
- Recruiting
CHU de Bordeaux
Bordeaux
Romain BOULESTREAU, 05 56 79 58 02, romain.boulestreau@chu-bordeaux.fr
- Recruiting
CH de Chalon sur Saône
Chalon-sur-Saône
Magali LOUIS, 03 85 44 66 88, Magali.Louis@ch-chalon71.fr
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Pierre Yves COURAND, 04 78 86 57 37, pierre-yves.courand@chu-lyon.fr
- Recruiting
APHP Avicenne
Paris
Marilucy LOPEZ SUBLET, 01 48 95 53 91, marilucy.lopez-sublet@aphp.fr
- Recruiting
Hôpital Européen Georges Pompidou
Paris
Aurélien LORTHIOIR, 01 56 09 37 76, aurelien.lorthioir@aphp.fr
- Recruiting
Hôpital Paris Saint Joseph
Paris
Yara HANON - ANTAKLY, 01 44 12 79 13, YAntakly@hpsj.fr
- Recruiting
CHU de Strasbourg
Strasbourg
Dominique STEPHAN, 03 69 55 05 83, Dominique.stephan@chru-strasbourg.fr
- Recruiting
CHU de Toulouse
Toulouse
Béatrice DULY-BOUHANICK, 05 61 32 21 59, duly-bouhanick.b@chu-toulouse.fr
- Recruiting
CHRU de Tours
Tours
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
About this study
The HAMA bank is an initiative aimed at collecting, preparing, and storing biological samples from patients treated for malignant hypertension and included in the HAMA cohort. Conducted under CRB (ISO20387) conditions, this biobank serves as an essential resource for understanding the disease's pathophysiology, as well as for identifying novel biomarkers and therapeutic targets
Read the detailed description
Malignant hypertension (MH) is an acute and severe form of hypertension that can lead to rapid target organ damage and potentially be fatal within months if not treated. Despite the severity, MH manifests in various phenotypes, suggesting multiple underlying pathophysiological pathways. The HAMA bank aims to address this by collecting biological samples at two distinct time-points:
For " Pre-existing Patients " in the HAMA cohort: A one-time collection focused on genetic analysis. A full sample (equivalent to sample 1 below) may be collected in option.
For Newly Diagnosed Patients (Incident Patients): Sample 1 "Acute Phase": Collected between Day 0 and Day 7 post-admission to any HAMA recruiting centers. This will be used for initial multi-omics analysis. Sample 2 "Chronic Phase": Collected between the 1st and 6th months during a follow-up visit at the investigating center.
These samples will be cross-referenced with clinical and biological data from the HAMA cohort. The cohort follow-up schedule is: 1, 3, 6, 12 months after MH diagnosis and annually for a total of 5 years.
- Conditions
- Malignant Hypertension
- Being tested
- biobank
- Keywords
- Malignant hypertension, severe hypertension, hypertensive emergency, target organ damage, pathophysiology, biomarkers
- Medical subject headings
- Hypertension, Malignant, Hypertension, Hypertensive Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biobankOther
The following samples will be collected :
- Serum samples and plasma sample: inclusion visit and follow up visit
- Urines samples : inclusion visit and follow up visit
- blood DNA: inclusion visit
- Blood RNA: inclusion visit and follow up visit
What is being measured
The primary outcome is the main question the study is designed to answer.
Decipher the mechanisms responsible for the transition from severe to malignant hypertension
Compare the multiomic signature of patients admitted for malignant hypertension, between MHT acute crisis (admission) and resolution (6 month later). Transcriptomic, proteomic and metabolomic evolution between these 2 time points and focus on genetic background in relevant system, like angiogenic, vasoactif system, complement system and inflammasome will be described.
Measured: At inclusion and 6 month
Secondary outcomes (2)
Understand the determinants of the heterogeneity in target organs damages (TOD) during MHT crisis
Patient's multiomic signature according to the number of target organ damage presented by the patients, the presence and severity of each TOD (heart, brain, kidney, retina and endothelium) will be compared
Measured: At inclusion
Focus on the role of complement system in MHT crisis
level of circulating complement factors and transcripts between the admission (acute phase of malignant hypertension) and the follow-up consultation will be specificaly compared. Prevalence of pathogenic variant involved in the complement system in the study population will described.
Measured: At inclusion and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start19 Mar 2026
- Primary completion1 Apr 2036 (estimated)
- Study completion1 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de PAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain BOULESTREAU, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629363
- Sponsor's protocol ID
- 2025-A01738-41
- Acronym
- HAMABANK
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Malignant Hypertension Onset and Related Target Organ Damages: the HAMA Biobank
- ClinicalTrials.gov ID
- NCT06629363
- Acronym / sponsor ID
- HAMABANK / 2025-A01738-41
- Conditions
- Malignant Hypertension
- Keywords
- Malignant hypertension, severe hypertension, hypertensive emergency, target organ damage, pathophysiology, biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier de PAUUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 1 Apr 2036 (estimated)
- Study completion
- 1 Apr 2036 (estimated)
- First posted
- 8 Oct 2024 (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.
The HAMA bank is an initiative aimed at collecting, preparing, and storing biological samples from patients treated for malignant hypertension and included in the HAMA cohort. Conducted under CRB (ISO20387) conditions, this biobank serves as an essential resource for understanding the disease's pathophysiology, as well as for identifying novel biomarkers and therapeutic targets
Detailed description
Malignant hypertension (MH) is an acute and severe form of hypertension that can lead to rapid target organ damage and potentially be fatal within months if not treated. Despite the severity, MH manifests in various phenotypes, suggesting multiple underlying pathophysiological pathways. The HAMA bank aims to address this by collecting biological samples at two distinct time-points:
For " Pre-existing Patients " in the HAMA cohort: A one-time collection focused on genetic analysis. A full sample (equivalent to sample 1 below) may be collected in option.
For Newly Diagnosed Patients (Incident Patients): Sample 1 "Acute Phase": Collected between Day 0 and Day 7 post-admission to any HAMA recruiting centers. This will be used for initial multi-omics analysis. Sample 2 "Chronic Phase": Collected between the 1st and 6th months during a follow-up visit at the investigating center.
These samples will be cross-referenced with clinical and biological data from the HAMA cohort. The cohort follow-up schedule is: 1, 3, 6, 12 months after MH diagnosis and annually for a total of 5 years.
Study design
- Observational model
- Other
- 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 (3 listed)
- patients included in the HAMA cohort with the following critera :
Key exclusion criteria (2 listed)
- Refusal to participate to the substudy " HAMA bank "
- patient on chronic dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biobankThe following samples will be collected : * Serum samples and plasma sample: inclusion visit and follow up visit * Urines samples : inclusion visit and follow up visit * blood DNA: inclusion visit * Blood RNA: inclusion visit and follow up visit | Other | – |
Primary outcome
Decipher the mechanisms responsible for the transition from severe to malignant hypertension
Time frame: At inclusion and 6 month
Compare the multiomic signature of patients admitted for malignant hypertension, between MHT acute crisis (admission) and resolution (6 month later). Transcriptomic, proteomic and metabolomic evolution between these 2 time points and focus on genetic background in relevant system, like angiogenic, vasoactif system, complement system and inflammasome will be described.
2 secondary outcomes
Understand the determinants of the heterogeneity in target organs damages (TOD) during MHT crisis
Time frame: At inclusion
Focus on the role of complement system in MHT crisis
Time frame: At inclusion and 6 month
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 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Malignant Hypertension
Not yet recruiting
Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT
Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruiting
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Type 2 Diabetes Mellitus, Obesity
RecruitingObservational study
A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort
Malignant Hypertension
Not yet recruiting
AI-Assisted Comprehensive Management for Cancer Patients With Comorbidities (GCOG-CG001)
Oncological Comorbidities (e. g. Hypertension, Diabetes, Malnutrition)
Enrolling by invitationObservational study
Risk Factors at Chronic Non-communicable Diseases in People of Working Age
Chronic Non-communicable Disease
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.
Romain BOULESTREAU principal investigator
University Hospital, Bordeaux
11 sites in 1 country: 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 11 sites in France.
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 3 inclusion and 2 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
Contact Alice SERIS (0559726997, alice.seris@ch-pau.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decipher the mechanisms responsible for the transition from severe to malignant hypertension (time frame: At inclusion and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.