Clinical trial NCT06629363: Creation of a Biobank of Biological Samples From Patients With Malignant Hypertension
Official title: Creation of a Biobank of Biological Samples From Patients With Malignant Hypertension Included in the HAMA Cohort: HAMA-BANK
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Malignant Hypertension
Keywords: Malignant hypertension
severe hypertension
hypertensive emergency
target organ damage
pathophysiology
biomarkers
Lead sponsor: Centre Hospitalier de PAU
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with malignant hypertension

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decipher the mechanisms responsible for the transition from severe to malignant hypertension
timeFrame: At inclusion and 6 month
Secondary outcomes:
measure: Understand the determinants of the heterogeneity in target organs damages (TOD) during MHT crisis
timeFrame: At inclusion
measure: Focus on the role of complement system in MHT crisis
timeFrame: At inclusion and 6 month
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Romain BOULESTREAU
role: PRINCIPAL_INVESTIGATOR
References: