NCT04991077

Brief Summary

The pathophysiology of malignant hypertension is poorly understood. The objective of this translational research project is to evaluate the relationship between activation of vasoactive systems (renin-angiotensin and endothelin systems), angiogenic signal deficiency (VEGF and sFlt-1) and the occurrence of malignant hypertension episodes in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

June 16, 2021

Last Update Submit

October 29, 2024

Conditions

Malignant Hypertension

Keywords

malignant hypertensionsevere hypertensionhypertensive emergencypathophysiologyangiogenic systeminflammasome

Outcome Measures

Primary Outcomes (1)

  • sFLT1 concentration at inclusion

    The primary endpoint will be the difference in sFLT1 concentrations between patients and controls at enrolment

    at the end of study recrutment, an average of 11 month

Secondary Outcomes (9)

  • IL1ß concentration at inclusion

    at the end of study recrutment, an average of 11 month

  • VEGF concentration at inclusion

    at the end of study recrutment, an average of 11 month

  • renin concentration at inclusion

    at the end of study recrutment, an average of 11 month

  • angiotensin concentration at inclusion

    at the end of study recrutment, an average of 11 month

  • evolution of IL1ß concentration

    through study completion, an average of 12 month

  • +4 more secondary outcomes

Study Arms (2)

patients group

patients with malignant hypertension

Biological: analyse of angiogenic, vasoactive and VEGF systems

Control group

patients with severe hypertension (Grade 2 or 3 hypertension)

Biological: analyse of angiogenic, vasoactive and VEGF systems

Interventions

analyse of angiogenic, vasoactive and VEGF systemsBIOLOGICAL

the angiogenic, vasoactive and VEGF systems will be analysed through blood and urine sampling. These samples will be collected at the time of malignant hypertension diagnosis and repeated one month later, in 30 patients (patients group). The same tests will be performed once in 15 patients with severe non-malignant hypertension, constituting the control group.

Control grouppatients group

Eligibility Criteria

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

patient group: patient with malignant hypertension control group: paitent with severe hypertension

You may qualify if:

  • Patients group :
  • Patients included in the HAMA cohort
  • Who is willing to take part in the IVAMA project
  • Control group :
  • Grade 2 or 3 hypertension with office blood pressure measurement (above 160 and/or 100 mmHg for systolic and diastolic)
  • Persistence of blood pressure above 160 / 100 mmHg on the average of 3 "attended" blood pressure measurements

You may not qualify if:

  • Patients group :
  • Age \< 18 years old
  • Patients with chronic renal failure of stage 3 or higher.
  • Patients with any type of diabetes
  • Patient in per partum
  • Patients who cannot freely give their consent, or patients who refuse to participate
  • Chronic dialysis patient
  • Control group:
  • Presence of known chronic kidney insufficiency of grade 3 or higher
  • Chronic dialysis patient
  • Diabetes of any type
  • Patients who cannot freely give their consent, or patients who refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hôpital Avicenne

Bobigny, France

Location

CHU de Bordeaux

Bordeaux, France

Location

Hôpital Bichat

Paris, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Tenon

Paris, France

Location

Chu Rangueil

Toulouse, France

Location

CHU de Tours

Tours, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Hypertension, MalignantHypertensionHypertensive Crisis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

June 16, 2021

First Posted

August 5, 2021

Study Start

February 7, 2022

Primary Completion

October 11, 2024

Study Completion

October 11, 2024

Last Updated

October 30, 2024

Record last verified: 2024-10

Locations

FR(7)