Interrupters of VAscular daMAge in Malignant Hypertension

NCT ID: NCT04991077

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-07

Study Completion Date

2024-10-11

Brief Summary

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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.

Detailed Description

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The pathophysiology of malignant hypertension is poorly understood. The current dogma is based on an overwhelming renin-angiotensin-aldosterone system activation, leading to arterial hypertension that overcomes target organ auto-regulatory mechanisms and leads to subacute microvascular lesions. However, some patients present with normal or lowered renin in the acute phase of malignant hypertension, suggesting other pathophysiological pathways. Malignant hypertension was reported following anti-VEGF treatment, suggesting that this pathway may be involved. Recent unpublished animal data highlight 1/ the possibility of severe deregulation of the VEGF (vascular endothelial growth factor) system in malignant hypertension 2/ the possibility of compensation of the vasculotoxic effects of VEGF deficiency by inflammasome components. These systems have never been studied together in human hypertension.

Investigators will analyze the angiogenic, vasoactive and VEGF systems 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. The same tests will be performed in 15 patients with severe non-malignant hypertension, constituting the control group.

Conditions

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Malignant Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients group

patients with malignant hypertension

analyse of angiogenic, vasoactive and VEGF systems

Intervention Type BIOLOGICAL

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 group

patients with severe hypertension (Grade 2 or 3 hypertension)

analyse of angiogenic, vasoactive and VEGF systems

Intervention Type BIOLOGICAL

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.

Interventions

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analyse of angiogenic, vasoactive and VEGF systems

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

* 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

Exclusion Criteria

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:
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de PAU

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Avicenne

Bobigny, , France

Site Status

CHU de Bordeaux

Bordeaux, , France

Site Status

Hôpital Bichat

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

Chu Rangueil

Toulouse, , France

Site Status

CHU de Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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CHPAU2021/02

Identifier Type: -

Identifier Source: org_study_id

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