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Determinants of Malignant Hypertension Onset and Related Target Organ Damages: the HAMA Biobank

Determinants of Malignant Hypertension Onset and Related Target Organ Damages: the HAMA Biobank

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06629363
Acronym
HAMABANK
Enrollment
1000
Registered
2024-10-08
Start date
2025-08-01
Completion date
2036-04-01
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Hypertension

Keywords

Malignant hypertension, severe hypertension, hypertensive emergency, target organ damage, pathophysiology, biomarkers

Brief 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 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.

Interventions

OTHERbiobank

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

Sponsors

Centre Hospitalier de PAU
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Refusal to participate to the substudy HAMA bank * patient on chronic dialysis

Design outcomes

Primary

MeasureTime frameDescription
Decipher the mechanisms responsible for the transition from severe to malignant hypertensionAt inclusion and 6 monthCompare 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.

Secondary

MeasureTime frameDescription
Understand the determinants of the heterogeneity in target organs damages (TOD) during MHT crisisAt inclusionPatient'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
Focus on the role of complement system in MHT crisisAt inclusion and 6 monthlevel 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.

Contacts

Primary ContactAlice SERIS
alice.seris@ch-pau.fr0559726997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026