Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629363
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Creation of a Biobank of Biological Samples from Patients with Malignant Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Creation of a Biobank of Biological Samples from Patients with Malignant Hypertension Included in the HAMA Cohort HAMA-BANK
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAMABANK
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 disease39s 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 34Acute Phase34 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 34Chronic Phase34 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
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 34Acute Phase34 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 34Chronic Phase34 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None