Interrupters of VAscular daMAge in Malignant Hypertension (NCT04991077) | Clinical Trial Compass
CompletedNot Applicable
Interrupters of VAscular daMAge in Malignant Hypertension
France45 participantsStarted 2022-02-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
sFLT1 concentration at inclusion
Timeframe: at the end of study recrutment, an average of 11 month