NCT06629363

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
121mo left

Started Aug 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Aug 2025Apr 2036

First Submitted

Initial submission to the registry

October 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2036

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

10.7 years

First QC Date

October 1, 2024

Last Update Submit

July 25, 2025

Conditions

Keywords

Malignant hypertensionsevere hypertensionhypertensive emergencytarget organ damagepathophysiologybiomarkers

Outcome Measures

Primary Outcomes (1)

  • 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.

    At inclusion and 6 month

Secondary Outcomes (2)

  • Understand the determinants of the heterogeneity in target organs damages (TOD) during MHT crisis

    At inclusion

  • Focus on the role of complement system in MHT crisis

    At inclusion and 6 month

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with malignant hypertension

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate to the substudy " HAMA bank "
  • patient on chronic dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for DNA

MeSH Terms

Conditions

Hypertension, MalignantHypertensionHypertensive Crisis

Interventions

Biological Specimen Banks

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Romain BOULESTREAU

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 8, 2024

Study Start

August 1, 2025

Primary Completion (Estimated)

April 1, 2036

Study Completion (Estimated)

April 1, 2036

Last Updated

July 30, 2025

Record last verified: 2025-07