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Interrupters of VAscular daMAge in Malignant Hypertension (IVAMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04991077
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de PAU

Study Description
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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.

Condition or disease Intervention/treatment
Malignant Hypertension Biological: analyse of angiogenic, vasoactive and VEGF systems

Detailed Description:

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 Recent unpublished animal data highlight 1/ the possibility of severe deregulation of the VEGF (vascular endothelial growth factor) system in malignant hypertension 2/ the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.

Study Design
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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Interrupters of VAscular daMAge in Malignant Hypertension: Role of Inflammasome, Angiogenic and Vasoactive System
Actual Study Start Date : February 7, 2022
Estimated Primary Completion Date : January 7, 2023
Estimated Study Completion Date : February 7, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
patients group
patients with malignant hypertension
 Biological: 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.
Control group
patients with severe hypertension (Grade 2 or 3 hypertension)
 Biological: 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.


Outcome Measures
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Primary Outcome Measures :
  1. sFLT1 concentration at inclusion [ Time Frame: at the end of study recrutment, an average of 11 month ]
    The primary endpoint will be the difference in sFLT1 concentrations between patients and controls at enrolment


Secondary Outcome Measures :
  1. IL1ß concentration at inclusion [ Time Frame: at the end of study recrutment, an average of 11 month ]
    Difference in IL1ß concentrations between patients and controls at enrolment

  2. VEGF concentration at inclusion [ Time Frame: at the end of study recrutment, an average of 11 month ]
    Difference in VEGF concentrations between patients and controls at enrolment

  3. renin concentration at inclusion [ Time Frame: at the end of study recrutment, an average of 11 month ]
    Difference in renin concentrations between patients and controls at enrolmentD30, and compare this evolution.

  4. angiotensin concentration at inclusion [ Time Frame: at the end of study recrutment, an average of 11 month ]
    Difference in angiotensin concentrations between patients and controls at enrolmentD30, and compare this evolution.

  5. evolution of IL1ß concentration [ Time Frame: through study completion, an average of 12 month ]
    Evaluation of the evolution of IL1ß concentration in the two groups between D0 and D30, and compare this evolution.

  6. evolution of VEGF concentration [ Time Frame: through study completion, an average of 12 month ]
    Evaluation of the evolution of VEGF concentration in the two groups between D0 and D30, and compare this evolution.

  7. evolution of renin concentration [ Time Frame: through study completion, an average of 12 month ]
    Evaluation of the evolution of renin concentration in the two groups between D0 and D30, and compare this evolution.

  8. evolution of angiotensin concentration [ Time Frame: through study completion, an average of 12 month ]
    Evaluation of the evolution of angiotensin concentration in the two groups between D0 and D30, and compare this evolution.

  9. mutations in the genes of interest [ Time Frame: through study completion, an average of 11 month ]
    comparison in the 2 groups of the frequency of mutations in the genes of interest underlying the vasoactive, angiogenic and VEGF systems


Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient group: patient with malignant hypertension control group: paitent with severe hypertension
Criteria

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

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:

  • Evidence of subacute involvement of one of the following target organs: brain, kidney, eye, heart, thrombotic microangiopathy. Target organ impairment is defined in the inclusion criteria for the "Patients" 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04991077


Locations
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France
Hôpital Avicenne Recruiting
Bobigny, France
Contact: Marilucy LOPEZ SUBLET    01 48 95 53 91    marilucy.lopez-sublet@aphp.fr   
CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Romain BOULESTREAU    05 59 92 48 83    romain.boulestreau@chu-bordeaux.fr   
Hôpital Bichat Recruiting
Paris, France
Contact: Emmanuelle VIDAL PETIOT    01 40 25 84 69    emmanuelle.vidal-petiot@aphp.fr   
Hôpital Européen Georges Pompidou Not yet recruiting
Paris, France
Contact: Aurélien LIORTHIOR         
Hôpital Tenon Not yet recruiting
Paris, France
Contact: Laurent MESNARD    01 56 01 65 02    laurent.mesnard@aphp.fr   
Chu Rangueil Recruiting
Toulouse, France
Contact: Beatrice DULY-BOUHANICK    05-61-32-21-59    duly-bouhanick.b@chu-toulouse.fr   
CHU de Tours Recruiting
Tours, France
Contact: Jean Michel HALIMI    02 47 47 37 46    halimi@med.univ-tours.fr   
Sponsors and Collaborators
Centre Hospitalier de PAU
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre Hospitalier de PAU
ClinicalTrials.gov Identifier: NCT04991077    
Other Study ID Numbers: CHPAU2021/02
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier de PAU:
malignant hypertension
severe hypertension
hypertensive emergency
 pathophysiology
angiogenic system
inflammasome
Additional relevant MeSH terms:
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Hypertension
Hypertension, Malignant
Vascular Diseases
Cardiovascular Diseases