Malignant HypertensionIVAMANCT04991077
Interrupters of VAscular daMAge in Malignant Hypertension
An observational study of Malignant Hypertension, run by Centre Hospitalier de PAU at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hypertension
- What is being tested?
- analyse of angiogenic, vasoactive and VEGF systems
- How many people
- 45 participants
- Where
- 7 sitesFrance
- Study dates
- 7 Feb 2022to 11 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient group: patient with malignant hypertension control group: paitent with severe hypertension
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hôpital Avicenne
Bobigny
CHU de Bordeaux
Bordeaux
Hôpital Bichat
Paris
Hôpital Européen Georges Pompidou
Paris
Hôpital Tenon
Paris
Chu Rangueil
Toulouse
CHU de Tours
Tours
About this study
Official title: Interrupters of VAscular daMAge in Malignant Hypertension: Role of Inflammasome, Angiogenic and Vasoactive System
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.
Read the 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.
- Conditions
- Malignant Hypertension
- Being tested
- analyse of angiogenic, vasoactive and VEGF systems
- Keywords
- malignant hypertension, severe hypertension, hypertensive emergency, pathophysiology, angiogenic system, inflammasome
- Medical subject headings
- Hypertension, Malignant, Hypertension, Hypertensive Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| patients group | patients with malignant hypertension Receives: Biological: analyse of angiogenic, vasoactive and VEGF systems | |
| Control group | patients with severe hypertension (Grade 2 or 3 hypertension) Receives: Biological: analyse of angiogenic, vasoactive and VEGF systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
sFLT1 concentration at inclusion
The primary endpoint will be the difference in sFLT1 concentrations between patients and controls at enrolment
Measured: at the end of study recrutment, an average of 11 month
Secondary outcomes (9)
IL1ß concentration at inclusion
Difference in IL1ß concentrations between patients and controls at enrolment
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: through study completion, an average of 11 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start7 Feb 2022
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de PAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991077
- Sponsor's protocol ID
- CHPAU2021/02
- Acronym
- IVAMA
- Status last verified
- Oct 2024
- First submitted
- 16 Jun 2021
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrupters of VAscular daMAge in Malignant Hypertension: Role of Inflammasome, Angiogenic and Vasoactive System
- ClinicalTrials.gov ID
- NCT04991077
- Acronym / sponsor ID
- IVAMA / CHPAU2021/02
- Conditions
- Malignant Hypertension
- Keywords
- malignant hypertension, severe hypertension, hypertensive emergency, pathophysiology, angiogenic system, inflammasome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier de PAUUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients group | – | Biological: analyse of angiogenic, vasoactive and VEGF systemspatients with malignant hypertension |
| Control group | – | Biological: analyse of angiogenic, vasoactive and VEGF systemspatients with severe hypertension (Grade 2 or 3 hypertension) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient group: patient with malignant hypertension control group: paitent with severe hypertension
Key inclusion criteria (6 listed)
- Patients included in the HAMA cohort
- Who is willing to take part in the IVAMA project
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analyse of angiogenic, vasoactive and VEGF systemsthe 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. | Biological | Control group, patients group |
Primary outcome
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
9 secondary outcomes
IL1ß concentration at inclusion
Time frame: at the end of study recrutment, an average of 11 month
VEGF concentration at inclusion
Time frame: at the end of study recrutment, an average of 11 month
renin concentration at inclusion
Time frame: at the end of study recrutment, an average of 11 month
angiotensin concentration at inclusion
Time frame: at the end of study recrutment, an average of 11 month
evolution of IL1ß concentration
Time frame: through study completion, an average of 12 month
evolution of VEGF concentration
Time frame: through study completion, an average of 12 month
evolution of renin concentration
Time frame: through study completion, an average of 12 month
evolution of angiotensin concentration
Time frame: through study completion, an average of 12 month
mutations in the genes of interest
Time frame: through study completion, an average of 11 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Hypertension, run by Centre Hospitalier de PAU at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sFLT1 concentration at inclusion (time frame: at the end of study recrutment, an average of 11 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.