Creation of a Biobank of Biological Samples From Patients With Malignant Hypertension

Not yet recruiting

• Conditions: Malignant Hypertension

• Registration Number: NCT06629363
• Lead Sponsor: Centre Hospitalier de PAU

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.

Study Timeline

• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-16
• Study Start: 2025-06-15
• Primary Completion: 2035-06-15
• Study Completion: 2035-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decipher the mechanisms responsible for the transition from severe to malignant hypertension	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.

Secondary Outcome Measures

Name	Time	Method
Focus on the role of complement system in MHT crisis	At inclusion and 6 month	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.
Understand the determinants of the heterogeneity in target organs damages (TOD) during MHT crisis	At inclusion	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