An observational study in Malignant Hypertension, sponsored by Centre Hospitalier de PAU. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Centre Hospitalier de PAU · Observational
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.
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 Recent unpublished animal data highlight 1/ the possibility of severe deregulation of the VEGF (vascular endothelial growth factor) system in malignant hypertension 2/ the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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 45 is below the median of 210 across 1,392 observational studies indexed under Hypertension.
Browse Hypertension studies →Centre Hospitalier de PAU is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
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patient group: patient with malignant hypertension control group: paitent with severe hypertension
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients group :
Control group :
Exclusion criteria:
Patients group :
Control group:
patients with malignant hypertension
Biological: analyse of angiogenic, vasoactive and VEGF systems
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.
sFLT1 concentration at inclusion
The primary endpoint will be the difference in sFLT1 concentrations between patients and controls at enrolment
Time frame: at the end of study recrutment, an average of 11 month
IL1ß concentration at inclusion
Difference in IL1ß concentrations between patients and controls at enrolment
Time frame: at the end of study recrutment, an average of 11 month
VEGF concentration at inclusion
Difference in VEGF concentrations between patients and controls at enrolment
Time frame: at the end of study recrutment, an average of 11 month
renin concentration at inclusion
Difference in renin concentrations between patients and controls at enrolmentD30, and compare this evolution.
Time frame: at the end of study recrutment, an average of 11 month
angiotensin concentration at inclusion
Difference in angiotensin concentrations between patients and controls at enrolmentD30, and compare this evolution.
Time frame: at the end of study recrutment, an average of 11 month
evolution of IL1ß concentration
Evaluation of the evolution of IL1ß concentration in the two groups between D0 and D30, and compare this evolution.
Time frame: through study completion, an average of 12 month
evolution of VEGF concentration
Evaluation of the evolution of VEGF concentration in the two groups between D0 and D30, and compare this evolution.
Time frame: through study completion, an average of 12 month
evolution of renin concentration
Evaluation of the evolution of renin concentration in the two groups between D0 and D30, and compare this evolution.
Time frame: through study completion, an average of 12 month
evolution of angiotensin concentration
Evaluation of the evolution of angiotensin concentration in the two groups between D0 and D30, and compare this evolution.
Time frame: through study completion, an average of 12 month
mutations in the genes of interest
comparison in the 2 groups of the frequency of mutations in the genes of interest underlying the vasoactive, angiogenic and VEGF systems
Time frame: through study completion, an average of 11 month
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de PAU